Clinical Insights: February 6, 2025

Welcome to Pillr Health’s Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace.

New Drug/Vaccine Approval

Journavx™ (suzetrigine) Tablets - formerly VX-548 – New Drug Approval – January 30, 2025 - The U.S. Food and Drug Administration approved Journavx™ (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx™ reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. Journavx™ is the first drug to be approved in this new class of pain management medicines. <Read More> 

Symbravo™ (meloxicam and rizatriptan) Tablets - formerly AXS-07 – New Drug Approval – January 30, 2025 - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (FDA) has approved Symbravo® (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Symbravo® represents a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. <Read More> 

Grafapex™ (treosulfan) Lyophilized Powder for Injection – New Drug Approval – January 22, 2025 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to provide a business update regarding the successful completion of the regulatory review process for Grafapex™ (treosulfan) for injection with the US Food and Drug Administration and, in addition, to announce preliminary estimates of the company's operating and financial results for the company's third fiscal quarter ended December 31, 2024 (which remain subject to completion of Medexus's financial closing procedures). All dollar amounts in this news release are in US dollars unless specified otherwise. <Read More> 

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Drug Approval – January 17, 2025 - The Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway®, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. <Read More> 

Opdivo® Qvantig™ (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection – New Drug Approval – December 27, 2024 - The Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo® Qvantig™, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo®, Bristol Myers Squibb Company) indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. <Read More> 

Alhemo® (concizumab-mtci) Injection – New Drug Approval – December 20, 2024 - The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Alyftrek™ (deutivacaftor, tezacaftor and vanzacaftor) – New Drug Approval – December 20, 2024 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved Alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to Alyftrek™. <Read More> 

Tryngolza™ (olezarsen) Injection – New Drug Approval – December 19, 2024 - The U.S. Food and Drug Administration has approved Tryngolza™ (olezarsen), used with diet, to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). This is a first-in-class approval, meaning Tryngolza™ uses a new mechanism of action, or works differently in the body, than other therapies currently used to treat FCS. Tryngolza™ is injected subcutaneously (under the skin) once per month. <Read More> 

Symvess™ (acellular tissue engineered vessel-tyod) for Surgical Vascular Implantation – New Drug Approval – December 19, 2024 - The U.S. Food and Drug Administration approved Symvess™, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible. Vascular trauma occurs when a blood vessel is injured such as a rupture of an artery in the extremities, which can lead to serious, life-threatening complications such as hemorrhage or blood clotting. <Read More> 

Ryoncil® (remestemcel-L-rknd) Cell Suspension for Intravenous Infusion – New Drug Approval – December 18, 2024 - The FDA approved remestemcel-L-rknd (brand name Ryoncil®), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older. Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy. <Read More> 

Ensacove™ (ensartinib) Capsules – New Drug Approval – December 18, 2024 - The Food and Drug Administration approved ensartinib (Ensacove™, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. <Read More> 

Crenessity™ (crinecerfont) Capsules and Oral Solution – New Drug Approval – December 13, 2024 - The U.S. Food and Drug Administration approved Crenessity™ (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH). <Read More>  

Unloxcyt™ (cosibelimab-ipdl) Injection – New Drug Approval – December 13, 2024 - The Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt™, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. <Read More> 

Bizengri® (zenocutuzumab-zbco) Injection – New Drug Approval – December 4, 2024 - The Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri®, Merus N.V.) for adults with the following:  1) advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or 2) advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy. This represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion. <Read More> 

Attruby™ (acoramidis) Tablets – New Drug Approval – November 25, 2024 - The U.S. Food and Drug Administration has approved Attruby™ (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems. ATTR-CM is a rare and serious disease that affects the heart muscle. In patients with ATTR-CM, there is a build-up of protein deposits in the heart, causing the walls of the heart to become stiff, and making the left ventricle unable to properly relax and fill with blood (called cardiomyopathy). As the condition progresses, the heart can become unable to pump blood out adequately, causing heart failure. <Read More> 

Imkeldi™ (imatinib mesylate) Oral Solution – New Drug Approval – November 22, 2024 - Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has approved Imkeldi™ (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers. “We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” said Sharon Cunningham, chief executive officer of Shorla. “Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area.” <Read More> 

Rapiblyk™ (landiolol) Lyophilized Powder for Injection – New Drug Approval – November 22, 2024 - AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk™ (landiolol) in the hospital critical care setting for the treatment of the severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter). The approval is based on clinical studies which demonstrated that Rapiblyk™ (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure. The approval will provide patients in the U.S. with a new treatment option and is an important step for AOP Health in bringing its mission to help patients and make an impact on rare diseases and critical care to the United States for the first time. <Read More> 

New Indication/Dosage/Formulation Approval

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – January 28, 2025 – AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. <Read More> 

Ozempic® (semaglutide) Injection – New Label Expansion – January 28, 2025 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. <Read More> 

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – January 27, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: Leqembi®) intravenous (IV) maintenance dosing. Leqembi® is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. <Read More> 

Spravato® (esketamine) Nasal Spray – New Label Expansion – January 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for Spravato® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. <Read More> 

Lumakras® (sotorasib) Tablets – New Label Expansion – January 16, 2025 – The Food and Drug Administration approved sotorasib (Lumakras®, Amgen Inc.) with panitumumab (Vectibix®, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. <Read More> 

Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – January 16, 2025 – AstraZeneca’s Calquence® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review. It was based on results from the ECHO Phase III trial which were presented at the European Hematology Association 2024 Congress. <Read More> 

Omvoh® (mirikizumab-mrkz) Injection – New Label Expansion – January 15, 2025 – Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults. Omvoh® is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults. <Read More> 

Niktimvo™ (axatilimab-csfr) Injection – New Label Expansion – January 15, 2025 – Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. The Companies expect product to be available for order in the U.S. in early February. Niktimvo™ is approved for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). Niktimvo™ is the first and only FDA-approved prescription treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis. <Read More>

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – December 26, 2024 – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1). <Read More> 

Zepbound® (tirzepatide) Injection – New Label Expansion – December 20, 2024 – Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound® may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a reduced-calorie diet and increased physical activity. <Read More>  

Braftovi® (encorafenib) Capsules – New Label Expansion – December 20, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. <Read More> 

Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules – New Label Expansion – December 20, 2024 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to Trikafta® based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. With this approval, 94 additional non-F508del CFTR mutations have been added to the Trikafta® label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to treat the underlying cause of their disease for the first time. <Read More> 

Imcivree® (setmelanotide) Injection – New Label Expansion – December 20, 2024 – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Imcivree® (setmelanotide) to include children as young as 2 years old. Imcivree® is indicated to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. <Read More> 

Gemtesa® (vibegron) Tablets – New Label Expansion – December 18, 2024 – Sumitomo Pharma America, Inc. (SMPA) announced that the U.S. Food and Drug Administration (FDA) has approved Gemtesa® (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH). This approval marks Gemtesa® as the first and only β3 agonist approved to treat patients living with OAB and being treated for BPH. It is currently available for prescription in the U.S. <Read More> 

Nemluvio® (nemolizumab) for Injection – New Label Expansion – December 13, 2024 – Galderma announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. This follows the recent U.S. FDA approval of Nemluvio® for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024. <Read More> 

Vtama® (tapinarof) Cream – New Label Expansion – December 12, 2024 – Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, announced that the U.S. Food and Drug Administration (FDA) has approved Vtama® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older. Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – December 4, 2024 – AstraZeneca’s Imfinzi® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the ADRIATIC Phase III trial which were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine. <Read More> 

Acetadote® (acetylcysteine) Injection – New Label Expansion – November 26, 2024 – Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote® (N-acetylcysteine for injection) product. Acetadote® is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen. <Read More> 

Bimzelx® (bimekizumab-bkzx) Injection – New Label Expansion – November 20, 2024 – UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). <Read More>  

New Drug Shortage

January 31, 2025

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January 24, 2025

Updated Drug Shortage

January 28, 2025

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January 22, 2025

New Drug Recall and Safety Alerts

Fentanyl Transdermal System 25 mcg/h by Alvogen – New Voluntary Recall – January 31, 2025 - Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor. <Read More>

Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) by Provepharm Inc. – New Voluntary Recall – January 24, 2025 - Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product. <Read More> 

New Generic/Biosimilar Approval and Launch

Avtozma® (tocilizumab-anoh) Injection – New Actemra® Biosimilar Approval – January 30, 2025 - Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Avtozma® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra®. Avtozma® is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19). <Read More> 

Steqeyma® (ustekinumab-stba) Injection – New Stelara® Biosimilar Approval – December 17, 2024 - Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. <Read More>  

Yesintek™ (ustekinumab-kfce) Injection – New Stelara® Biosimilar Approval – November 29, 2024 – Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Yesintek™ (ustekinumab-kfce), a biosimilar to the reference product, Stelara® (ustekinumab). <Read More> 

Clinical and Pharmacy News

Guidelines Call for Widespread Type 1 Diabetes Screening in Children – February 4, 2025 – A University of Florida Health physician-scientist led an international team of Type 1 diabetes experts who recently developed new treatment guidelines emphasizing wider screening for the disease among children and adolescents in the general population before symptoms arise. That would include screening the young relatives of those with Type 1 diabetes, such as siblings, because they are at higher genetic risk of developing diabetes. The effort was led by Michael Haller, M.D., chief of pediatric endocrinology in the UF College of Medicine's Department of Pediatrics and a member of the UF Diabetes Institute. The guidelines cover screening, staging, and strategies to preserve beta cell function in children and adolescents with Type 1 diabetes. <Read More> 

Trump Tariffs Will Escalate Costs and Disrupt the Medical Supply Chain, Industry Execs Warn – February 3, 2025 – Double-digit tariffs, if they take effect as proposed, threaten to escalate healthcare costs, disrupt supply chains and create affordability challenges for patients, healthcare executives say. President Donald Trump on Saturday signed executive orders intending to impose sweeping tariffs on the country’s three largest trading partners. The Trump administration imposed 25% tariffs on imports from Canada and Mexico plus a 10% tariff on Chinese imports. <Read More> 

Automated Follow-up Alerts Pharmacists to Cancer Patients’ Needs – January 28, 2025 – Early automated follow-up of cancer patients can help pharmacists more efficiently manage side effects of oral oncolytic medications, according to data presented at the ASHP Midyear 2024 Clinical Meeting & Exhibition, in New Orleans (poster 4-058). To improve adverse event (AE) detection and prevention, a team from Vanderbilt University Medical Center’s Specialty Pharmacy, in Nashville Tenn., sent an electronic early monitoring questionnaire to patients who were starting oral anticancer treatment. The questionnaire, distributed via the patient portal inbox, “resulted in higher [rates of], and faster time to, pharmacists identifying and addressing AEs from newly initiated oral anticancer therapy in patients who responded compared to those who did not respond or were in the usual-care arm,” explained presenter Brooke Looney, PharmD, CSP, the oncology/hematology clinical lead at Vanderbilt. <Read More> 

AI’s Potential in Women’s Health Exciting, Says Gates Foundation Leader – January 21, 2025 – The health disparity between women and men is a pressing global challenge, experts highlighted in a discussion at the World Economic Forum Annual Meeting 2025 in Switzerland. Despite comprising half the global population, women spend 25% more of their lives in poor health compared to men, according to a 2024 report by the World Economic Forum and McKinsey Health Institute. Addressing this gap could not only improve millions of lives, but also add at least $1trn to the global economy annually by 2040, said Anita Zaidi, president of gender equality at the Bill & Melinda Gates Foundation, quoting the report. Innovations in artificial intelligence (AI), digital health tools, and cross-sector collaboration are expected to help bridge this disparity. <Read More> 

Will PBM Reform Save Pharmacies From Closing? – January 15, 2025 – In May 2024, nearly 90% of pharmacies were closed for a day as thousands of pharmacists protested over “over drug shortages, pharmacy closures and fears medications could be sold online, as well as higher pay.” More recently in November 2024, pharmacy owners voted in favor of cutting hours and stopping home deliveries in a protest over funding. Given multiple recent news articles saying that pharmacies are struggling amid problems caused by pharmacy benefit managers (PBMs) , you might not be surprised by these examples. However, these two news stores are not from the U.S. They are from France and the United Kingdom — two countries that do not have the large PBMs that are frequently criticized in America. <Read More> 

Despite Risks and Scant Evidence, Muscle Relaxants Still Used to Treat Chronic Pain – January 14, 2025 – The CDC has guidelines recommending that clinicians avoid using opioids to manage chronic noncancer pain. Now data published in JAMA Network Open indicate that as physicians heed opioid guidelines, prescriptions for skeletal muscle relaxants (SMRs) for chronic pain have risen—despite risks posed by SMRs and a lack of evidence supporting their long-term use (JAMA Network Open 2024;7[9]:e2434835). “This means that, when thinking about using muscle relaxants for chronic pain conditions, we should be vigilant and cautious,” said study author Benjamin J. Oldfield, MD, an internal medicine/pediatric specialist at the Yale School of Medicine, in New Haven, Conn. “As physicians, it may not be the right option to prescribe, and to continue to refill, muscle relaxants for the majority of chronic pain conditions.” <Read More> 

Drugmakers Hiked Prices for Hundreds of Drugs in Early January – January 14, 2025 – Drugmakers raised the list prices on 575 name-brand drugs in just the first two days of the new year, according to drug price research firm 46brooklyn. Drugs for diabetes, HIV, cancer saw price hikes, among others. For years a 10% annual price hike was fairly normal, but they've started coming down in recent years. This year's median price hike so far is only 4%, says Antonio Ciaccia, CEO of 46brooklyn. "While it's early, if that number held throughout the year, that would make it the lowest median price increase in over a decade," says Ciaccia. January is typically a popular time to raise prices on brand name drugs, but companies can raise them throughout the year. There could even be more later this month, he says. <Read More> 

Clearing the Path for New Uses for Generic Drugs – January 9, 2025 – Repurposing generic drugs as new treatments for life-threatening diseases is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. The low profit margins for generic drugs mean that pharmaceutical companies rarely invest in research, regulatory efforts, and marketing for new uses. Nonprofit organizations and other non-commercial non-manufacturers are increasing efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. <Read More> 

Pharmacological Treatment in Autism: A Proposal for Guidelines on Common Co-Occurring Psychiatric Symptoms – January 7, 2025 – The prevalence of autism spectrum disorder (ASD) has surged, with an estimated 1 in 36 eight-year-olds in the United States meeting criteria for ASD in 2020. Autistic individuals face elevated rates of co-occurring medical, psychiatric, and behavioral conditions compared to non-autistic individuals. The rising ASD-patient demand is increasingly outpacing the capacity of ASD-specialty clinics, resulting in urgent need for autism-competent providers in general practice settings. This work aims to empower healthcare providers, especially primary care providers (PCPs), with guidelines for the recognition and safe pharmacologic management of common co-occurring psychiatric and behavioral conditions in ASD. <Read More> 

Senate Introduces Bipartisan Bill to Ban Co‑ownership of Pharmacies and Pharmacy Benefits Managers – December 13, 2024 – Senators Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., introduced in the Senate the Patients Before Monopolies Act (PBM Act), a bill “[t]o prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes.” The PBM Act would make it unlawful for any person to “own, operate, control, or direct the operation of” any type of pharmacy if that person also “own[s], operate[s], or control[s]” an insurance company or pharmacy benefits manager (PBM). This bill follows nearly a year of heightened government scrutiny of PBMs and allegations of harm resulting from vertical integration and price fixing. If passed, the PBM Act would prevent PBMs and payors from being in a position of control over pharmacies through which they can affect the competitive harms alleged. <Read More> 

Drugmakers and Pharmacists Battle Over Who Gets to Make Obesity Drugs – December 12, 2024 – Ozempic® and similar drugs for Type 2 diabetes and weight loss are in such high demand that the drugmakers have had a hard time keeping up. So compounding pharmacies stepped in to fill the gap, making their own versions of the drugs for more than two years. The compounded versions are especially popular as cheaper alternatives for people whose insurance doesn't cover them. But now the brand name manufacturers are pushing the compounding pharmacies to stop. Novo Nordisk and Eli Lilly are moving to end compounding of their medicines for good. <Read More> 

Pharmacists’ Key Role in the Management of Humira Biosimilars – November 27, 2024 – The introduction of adalimumab (Humira®, AbbVie) biosimilars to the US market in 2023 brought significant changes for providers, patients, and pharmacies. Since its introduction in 2002, Humira has been one of the world’s bestselling drugs for treating inflammatory conditions…Pharmacists have been challenged in managing the complexity of switching patients from the reference product to various biosimilars, including navigating clinical appropriateness, education, insurance, affordability, and several practical hurdles. We aim to provide an update on what is new, what we have learned over the past 12 months, and what we are anticipating in the Humira biosimilar market. <Read More> 

ASTRO Releases Updated Guidelines for Treating Locally Advanced Rectal Cancer – November 25, 2024 – The American Society for Radiation Oncology (ASTRO) issued an updated clinical guideline for physicians who use radiation therapy to treat patients with locally advanced rectal cancer. This update incorporates new data on patient selection and best practices from several practice-changing clinical trials published since the prior guideline was issued in 2020. The updated ASTRO guideline is published in Practical Radiation Oncology. <Read More> 

Top Three Pharmacy Benefit Managers Will Face FTC in Joint Trial for Insulin Rebate Cases – November 20, 2024 – Administrative Law Judge D. Michael Chappell ordered that the country’s largest pharmacy benefit managers (PBMs) have to face the FTC together in an administrative case. The case alleges that the three largest PBMs―Caremark, Express Scripts and OptumRX―used unfair rebate schemes to artificially inflate the price of insulin. In mid-October, the PBMs each moved for separate proceedings, arguing that a consolidated trial could create confusion. The judge held that the factual differences in each of the cases were “minimal and manageable.” Judge Chappell noted that many of the respondents’ arguments regarding confusion of the evidence cited to authority regarding jury trials, but the current case is a bench trial. <Read More> 

Market Trends to Watch for Health Systems and Their Specialty Pharmacies – November 18, 2024 – The overall market for specialty medications has grown dramatically over the past decade, and that trend is expected to continue for at least the next five years. Health systems, patients and pharmacies will experience shifting market dynamics that add challenges to providing specialty care, including price increases, an aging population driving increased utilization and a growing wave of innovative therapies that add new patients to the specialty pool. In response, health systems have sharpened their focus on integrating specialty pharmacy care to now include pharmacy needs within their hospitals to help improve patient outcomes and experiences. <Read More> 

Management of Stage III Non–Small Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update Clinical Insights – November 18, 2024 – Stage III non–small cell lung cancer (NSCLC) is a highly heterogeneous disease with a range of treatment options that have been highlighted in the ASCO guidelines (Figs 1 and 2).1-3 Historically, treatment was largely determined by resectability and nodal extent, without personalization on the basis of molecular subtype. Several recent trials favor molecular profile–guided precision therapy of both resectable and unresectable stage III NSCLC: highlighting the need for guideline-concordant biomarker testing for all patients with stage III NSCLC. In addition, new data address incorporation of perioperative immunotherapy, expanding treatment options for patients with resectable disease. This article provides additional context and insight into common clinical situations encountered by oncologists with a review of recent trials that update the standard of care for both resectable and unresectable stage III NSCLC. <Read More>

340B in the News

New Administration’s Impact on 340B Program: TBD – January 16, 2025 – How could the second Trump administration affect the federal 340B Drug Pricing Program? It’s yet to be determined, according to policy experts. Predicting how the election could ultimately affect the program “is above my pay grade,” joked Maureen Testoni, JD, the president and CEO of 340B Health, a nonprofit organization representing more than 1,500 hospitals and health systems that participate in the 340B program. However, during President-elect Donald Trump’s prior term, “we didn’t see a lot of action on 340B,” she said in a Nov. 19 press briefing. Early on in that administration, Medicare cut its reimbursement for Part B 340B drugs by nearly 30% and redistributed the money through higher payments for nondrug services to all hospitals paid under the Medicare Outpatient Prospective Payment System, Ms. Testoni said. But hospital associations sued over the cuts, and the U.S. Supreme Court overturned them in 2022. <Read More> 

Clinical Insights: August 6th, 2025

New Drug/Vaccine Approval

Vizz™ (aceclidine) Ophthalmic Solution - formerly LNZ100 – New Drug Approval – July 31, 2025 – LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), announced the US Food and Drug Administration (“FDA”) approved Vizz™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately. <Read More>

Sephience™ (sepiapterin) Oral Powder – New Drug Approval – July 28, 2025 - PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive PKU. <Read More> 

Anzupgo® (delgocitinib) Topical Cream - New Drug Approval – July 23, 2025 - LEO Pharma, a global leader in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Anzupgo® is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. <Read More>

New Label Expansions

Alhemo® (concizumab-mtci) Injection – New Label Expansion – July 31, 2025 – The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Leqvio® (inclisiran) Injection - New Label Expansion – July 31, 2025 - Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. <Read More>

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets - New Label Expansion – July 30, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy®’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. <Read More> 

Empaveli® (pegcetacoplan) Injection - New Label Expansion – July 28, 2025 - Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States. <Read More>

Skytrofa® (lonapegsomatropin-tcgd) Lyophilized Powder for Injection – New Label Expansion – July 28, 2025 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. <Read More> 

Doptelet® (avatrombopag) Tablets and Oral Granules - New Label Expansion – July 25, 2025 - Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy.  The approval also includes a new formulation, Doptelet® Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years. <Read More>

Shingrix® (zoster vaccine recombinant, adjuvanted) Injection - New Label Expansion – July 17, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix® (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. <Read More> 

Kerendia® (finerenone) Tablets - New Label Expansion – July 14, 2025 - Bayer announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). <Read More>

Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – July 10, 2025 - Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA). <Read More> 

Kisunla™ (donanemab-azbt) Injection - New Label Expansion – July 9, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla™ (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. <Read More>

New Drug Shortage

August 4, 2025

August 1, 2025

July 29, 2025

July 28, 2025

July 24, 2025

July 23, 2025

July 21, 2025

July 17, 2025

Updated Drug Shortage

August 4, 2025

August 1, 2025

July 31, 2025

July 28, 2025

July 25, 2025

July 24, 2025

July 23, 2025

July 22, 2025

July 18, 2025

July 17, 2025

New Drug Recall and Safety Alerts

Sucralfate Tablets USP 1 Gram by Nostrum Laboratories, Inc. – New Voluntary Recall – July 14, 2025 – Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities. This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. <Read More> 

New Generic/Biosimilar Approval and Launch

Kirsty™ (insulin aspart-xjhz) Injection - New NovoLog® Biosimilar Approval – July 15, 2025 - Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart). Kirsty™ is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Kirsty™ will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. <Read More>

Clinical and Pharmacy News

PBM Markets are at Risk of Harming Patients – July 31, 2025 – The American Medical Association (AMA) published a new annual analysis (PDF) measuring competition in pharmacy benefit manager (PBM) markets and vertical integration of insurers with PBMs. The assessment demonstrates low competition in PBM markets across the nation and high vertical integration as the largest PBMs share ownership with health insurers. The AMA analysis adds to growing concern over anticompetitive harm resulting from low competition and high vertical integration in the PBM industry. It comes on the heels of reports by the Federal Trade Commission and U.S. House Committee on Oversight and Accountability finding that a handful of PBMs have vast power and control over medication access and affordability. <Read More> 

First Guideline on Alzheimer’s Blood-Based Biomarker Tests Released – July 31, 2025 – An expert panel convened by the Alzheimer’s Association has released the first clinical guidelines to help clinicians choose the most appropriate blood-based biomarker (BBM) test to aid in the diagnosis of Alzheimer’s disease (AD). The evidence-based guideline recommends that tests with ≥ 90% sensitivity and specificity can serve as a substitute for amyloid PET or cerebrospinal fluid (CSF) biomarker testing. Tests with ≥ 90% sensitivity but only ≥ 75% specificity should be used as a triaging test. In this case, a negative result rules out AD pathology with high probability and a positive result should be confirmed with CSF or PET testing. <Read More>

This Year’s Prescription Drug Bills Aim to Reduce Consumer Costs – July 30, 2025 – More than 800 prescription drug access and affordability proposals were introduced across all 50 states, Washington, D.C., and the territories in this year’s legislative sessions. The more than 130 enacted bills included some familiar policies as well as some new ones. Lawmakers were looking for ways to hold costs down through pharmacy benefit manager (PBM) reform, with more than 40 states considering some 270 PBM-related bills. Several themes emerged, including  Prohibiting spread pricing. States may enter contractual arrangements with PBMs to administer state employee health plan and Medicaid prescription benefits. Spread pricing, which is a traditional PBM business model, is a contractual agreement where an insurer or employer pays a higher amount for a prescription drug than the PBM reimbursement to the pharmacy. The PBM then keeps a portion of the spread. Regulating agencies in several states have raised concerns over the spread PBMs retain. <Read More> 

Drugmaker Novo Nordisk Slashes Wegovy® Sales Forecasts, Blaming Compounding – July 29, 2025 – Novo Nordisk's shares plunged more than 20% Tuesday, after the company cut the forecast for its flagship obesity drug. Before the markets opened, the company announced that sales of its obesity medicine, Wegovy®, are expected to grow no more than 14% this year. That's down from its prediction of up to 21% on May 7. The company blames cheaper alternatives made by compounding pharmacies, which are allowed to make what are essentially copies of drugs when they're in short supply. Wegovy® and Ozempic®, a diabetes drug sometimes prescribed for weight loss, had been on the Food and Drug Administration's drug shortage list, paving the way for a boom in compounded versions. <Read More> 

Delinking Pharmacy Benefit Manager Compensation From Drug List Prices Could Unleash Major Savings – July 24, 2025 – Breaking the link between prescription drug list prices and compensation to middlemen like pharmacy benefit managers (PBMs) could cut a significant portion of the U.S.'s annual drug tab, finds a new analysis from the USC Schaeffer Center for Health Policy & Economics. The work is published in the journal Health Affairs Scholar. PBMs, who negotiate drug benefits on behalf of insurers and employers, are typically paid based on a percentage of a drug's list price before rebates and other discounts are applied. Federal and state policymakers have proposed delinking PBM compensation from list prices in response to evidence that PBMs often steer patients toward higher-priced drugs—even when cheaper alternatives are available—to boost their own profits. <Read More> 

New Biosimilars Metric Confirms Switching Efficacy – July 23, 2025 – Most patients who were switched from adalimumab (Humira®, AbbVie) to an interchangeable biosimilar experienced clinical success, with the vast majority remaining on a biosimilar three months after conversion, according to a study conducted at Brown University Health and presented in a poster (38-M) at the ASHP Pharmacy Futures 2025 meeting. The study used data from the center’s electronic health records and specialty pharmacy from Jan. 1, 2023, to June 1, 2024. The primary objective was to evaluate the rate of reversion to the reference product three months after a payor mandated a switch to a biosimilar. <Read More>

Specialty Pharmacies Can Dispense the Emotional Script to Support Patients – July 23, 2025 – Behind every specialty medication is a person facing uncertainty. As this market surges toward unprecedented growth over the next decade, specialty pharmacies are increasingly turning to automation to meet demand and manage costs. However, while efficiency metrics climb, something essential gets lost—the human experience. Specialty pharmacies that prioritize efficiency over empathy risk missing what matters most: meaningful connection during a critical moment in care. Research suggests that adherence may be influenced not only by logistical or clinical barriers but also by emotional and psychological factors, such as fear, uncertainty, and loneliness. <Read More> 

HHS and Private Health Insurers Team Up to Improve Prior Authorization Process – July 14, 2025 - Stakeholders from federal health agencies and leading payors have pledged to streamline the often burdensome prior authorization process that can lead to delays in treatment and poorer clinical outcomes. The new pledge, by America’s Health Insurance Plans (AHIP), a trade organization representing many health insurance companies, was at the center of a recent roundtable discussion that AHIP held with Health and Human Services Secretary Robert F. Kennedy Jr., and Mehmet Oz, MD, the administrator of the  Centers for Medicare & Medicaid Services (CMS). <Read More> 

340B in the News

HHS Announces New 340B Rebate Model Pilot Program – July 31, 2025 – The Department of Health and Human Services issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date. <Read More> 


Clinical Insights: August 6th, 2025

New Drug/Vaccine Approval

Vizz™ (aceclidine) Ophthalmic Solution - formerly LNZ100 – New Drug Approval – July 31, 2025 – LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), announced the US Food and Drug Administration (“FDA”) approved Vizz™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately. <Read More>

Sephience™ (sepiapterin) Oral Powder – New Drug Approval – July 28, 2025 - PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive PKU. <Read More> 

Anzupgo® (delgocitinib) Topical Cream - New Drug Approval – July 23, 2025 - LEO Pharma, a global leader in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Anzupgo® is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. <Read More>

New Label Expansions

Alhemo® (concizumab-mtci) Injection – New Label Expansion – July 31, 2025 – The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Leqvio® (inclisiran) Injection - New Label Expansion – July 31, 2025 - Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. <Read More>

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets - New Label Expansion – July 30, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy®’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. <Read More> 

Empaveli® (pegcetacoplan) Injection - New Label Expansion – July 28, 2025 - Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States. <Read More>

Skytrofa® (lonapegsomatropin-tcgd) Lyophilized Powder for Injection – New Label Expansion – July 28, 2025 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. <Read More> 

Doptelet® (avatrombopag) Tablets and Oral Granules - New Label Expansion – July 25, 2025 - Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy.  The approval also includes a new formulation, Doptelet® Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years. <Read More>

Shingrix® (zoster vaccine recombinant, adjuvanted) Injection - New Label Expansion – July 17, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix® (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. <Read More> 

Kerendia® (finerenone) Tablets - New Label Expansion – July 14, 2025 - Bayer announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). <Read More>

Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – July 10, 2025 - Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA). <Read More> 

Kisunla™ (donanemab-azbt) Injection - New Label Expansion – July 9, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla™ (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. <Read More>

New Drug Shortage

August 4, 2025

August 1, 2025

July 29, 2025

July 28, 2025

July 24, 2025

July 23, 2025

July 21, 2025

July 17, 2025

Updated Drug Shortage

August 4, 2025

August 1, 2025

July 31, 2025

July 28, 2025

July 25, 2025

July 24, 2025

July 23, 2025

July 22, 2025

July 18, 2025

July 17, 2025

New Drug Recall and Safety Alerts

Sucralfate Tablets USP 1 Gram by Nostrum Laboratories, Inc. – New Voluntary Recall – July 14, 2025 – Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities. This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. <Read More> 

New Generic/Biosimilar Approval and Launch

Kirsty™ (insulin aspart-xjhz) Injection - New NovoLog® Biosimilar Approval – July 15, 2025 - Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart). Kirsty™ is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Kirsty™ will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. <Read More>

Clinical and Pharmacy News

PBM Markets are at Risk of Harming Patients – July 31, 2025 – The American Medical Association (AMA) published a new annual analysis (PDF) measuring competition in pharmacy benefit manager (PBM) markets and vertical integration of insurers with PBMs. The assessment demonstrates low competition in PBM markets across the nation and high vertical integration as the largest PBMs share ownership with health insurers. The AMA analysis adds to growing concern over anticompetitive harm resulting from low competition and high vertical integration in the PBM industry. It comes on the heels of reports by the Federal Trade Commission and U.S. House Committee on Oversight and Accountability finding that a handful of PBMs have vast power and control over medication access and affordability. <Read More> 

First Guideline on Alzheimer’s Blood-Based Biomarker Tests Released – July 31, 2025 – An expert panel convened by the Alzheimer’s Association has released the first clinical guidelines to help clinicians choose the most appropriate blood-based biomarker (BBM) test to aid in the diagnosis of Alzheimer’s disease (AD). The evidence-based guideline recommends that tests with ≥ 90% sensitivity and specificity can serve as a substitute for amyloid PET or cerebrospinal fluid (CSF) biomarker testing. Tests with ≥ 90% sensitivity but only ≥ 75% specificity should be used as a triaging test. In this case, a negative result rules out AD pathology with high probability and a positive result should be confirmed with CSF or PET testing. <Read More>

This Year’s Prescription Drug Bills Aim to Reduce Consumer Costs – July 30, 2025 – More than 800 prescription drug access and affordability proposals were introduced across all 50 states, Washington, D.C., and the territories in this year’s legislative sessions. The more than 130 enacted bills included some familiar policies as well as some new ones. Lawmakers were looking for ways to hold costs down through pharmacy benefit manager (PBM) reform, with more than 40 states considering some 270 PBM-related bills. Several themes emerged, including  Prohibiting spread pricing. States may enter contractual arrangements with PBMs to administer state employee health plan and Medicaid prescription benefits. Spread pricing, which is a traditional PBM business model, is a contractual agreement where an insurer or employer pays a higher amount for a prescription drug than the PBM reimbursement to the pharmacy. The PBM then keeps a portion of the spread. Regulating agencies in several states have raised concerns over the spread PBMs retain. <Read More> 

Drugmaker Novo Nordisk Slashes Wegovy® Sales Forecasts, Blaming Compounding – July 29, 2025 – Novo Nordisk's shares plunged more than 20% Tuesday, after the company cut the forecast for its flagship obesity drug. Before the markets opened, the company announced that sales of its obesity medicine, Wegovy®, are expected to grow no more than 14% this year. That's down from its prediction of up to 21% on May 7. The company blames cheaper alternatives made by compounding pharmacies, which are allowed to make what are essentially copies of drugs when they're in short supply. Wegovy® and Ozempic®, a diabetes drug sometimes prescribed for weight loss, had been on the Food and Drug Administration's drug shortage list, paving the way for a boom in compounded versions. <Read More> 

Delinking Pharmacy Benefit Manager Compensation From Drug List Prices Could Unleash Major Savings – July 24, 2025 – Breaking the link between prescription drug list prices and compensation to middlemen like pharmacy benefit managers (PBMs) could cut a significant portion of the U.S.'s annual drug tab, finds a new analysis from the USC Schaeffer Center for Health Policy & Economics. The work is published in the journal Health Affairs Scholar. PBMs, who negotiate drug benefits on behalf of insurers and employers, are typically paid based on a percentage of a drug's list price before rebates and other discounts are applied. Federal and state policymakers have proposed delinking PBM compensation from list prices in response to evidence that PBMs often steer patients toward higher-priced drugs—even when cheaper alternatives are available—to boost their own profits. <Read More> 

New Biosimilars Metric Confirms Switching Efficacy – July 23, 2025 – Most patients who were switched from adalimumab (Humira®, AbbVie) to an interchangeable biosimilar experienced clinical success, with the vast majority remaining on a biosimilar three months after conversion, according to a study conducted at Brown University Health and presented in a poster (38-M) at the ASHP Pharmacy Futures 2025 meeting. The study used data from the center’s electronic health records and specialty pharmacy from Jan. 1, 2023, to June 1, 2024. The primary objective was to evaluate the rate of reversion to the reference product three months after a payor mandated a switch to a biosimilar. <Read More>

Specialty Pharmacies Can Dispense the Emotional Script to Support Patients – July 23, 2025 – Behind every specialty medication is a person facing uncertainty. As this market surges toward unprecedented growth over the next decade, specialty pharmacies are increasingly turning to automation to meet demand and manage costs. However, while efficiency metrics climb, something essential gets lost—the human experience. Specialty pharmacies that prioritize efficiency over empathy risk missing what matters most: meaningful connection during a critical moment in care. Research suggests that adherence may be influenced not only by logistical or clinical barriers but also by emotional and psychological factors, such as fear, uncertainty, and loneliness. <Read More> 

HHS and Private Health Insurers Team Up to Improve Prior Authorization Process – July 14, 2025 - Stakeholders from federal health agencies and leading payors have pledged to streamline the often burdensome prior authorization process that can lead to delays in treatment and poorer clinical outcomes. The new pledge, by America’s Health Insurance Plans (AHIP), a trade organization representing many health insurance companies, was at the center of a recent roundtable discussion that AHIP held with Health and Human Services Secretary Robert F. Kennedy Jr., and Mehmet Oz, MD, the administrator of the  Centers for Medicare & Medicaid Services (CMS). <Read More> 

340B in the News

HHS Announces New 340B Rebate Model Pilot Program – July 31, 2025 – The Department of Health and Human Services issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date. <Read More> 


Clinical Insights: August 6th, 2025

New Drug/Vaccine Approval

Vizz™ (aceclidine) Ophthalmic Solution - formerly LNZ100 – New Drug Approval – July 31, 2025 – LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), announced the US Food and Drug Administration (“FDA”) approved Vizz™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately. <Read More>

Sephience™ (sepiapterin) Oral Powder – New Drug Approval – July 28, 2025 - PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive PKU. <Read More> 

Anzupgo® (delgocitinib) Topical Cream - New Drug Approval – July 23, 2025 - LEO Pharma, a global leader in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Anzupgo® is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. <Read More>

New Label Expansions

Alhemo® (concizumab-mtci) Injection – New Label Expansion – July 31, 2025 – The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Leqvio® (inclisiran) Injection - New Label Expansion – July 31, 2025 - Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. <Read More>

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets - New Label Expansion – July 30, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy®’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. <Read More> 

Empaveli® (pegcetacoplan) Injection - New Label Expansion – July 28, 2025 - Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States. <Read More>

Skytrofa® (lonapegsomatropin-tcgd) Lyophilized Powder for Injection – New Label Expansion – July 28, 2025 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. <Read More> 

Doptelet® (avatrombopag) Tablets and Oral Granules - New Label Expansion – July 25, 2025 - Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy.  The approval also includes a new formulation, Doptelet® Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years. <Read More>

Shingrix® (zoster vaccine recombinant, adjuvanted) Injection - New Label Expansion – July 17, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix® (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. <Read More> 

Kerendia® (finerenone) Tablets - New Label Expansion – July 14, 2025 - Bayer announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). <Read More>

Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – July 10, 2025 - Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA). <Read More> 

Kisunla™ (donanemab-azbt) Injection - New Label Expansion – July 9, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla™ (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. <Read More>

New Drug Shortage

August 4, 2025

August 1, 2025

July 29, 2025

July 28, 2025

July 24, 2025

July 23, 2025

July 21, 2025

July 17, 2025

Updated Drug Shortage

August 4, 2025

August 1, 2025

July 31, 2025

July 28, 2025

July 25, 2025

July 24, 2025

July 23, 2025

July 22, 2025

July 18, 2025

July 17, 2025

New Drug Recall and Safety Alerts

Sucralfate Tablets USP 1 Gram by Nostrum Laboratories, Inc. – New Voluntary Recall – July 14, 2025 – Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities. This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. <Read More> 

New Generic/Biosimilar Approval and Launch

Kirsty™ (insulin aspart-xjhz) Injection - New NovoLog® Biosimilar Approval – July 15, 2025 - Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart). Kirsty™ is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Kirsty™ will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. <Read More>

Clinical and Pharmacy News

PBM Markets are at Risk of Harming Patients – July 31, 2025 – The American Medical Association (AMA) published a new annual analysis (PDF) measuring competition in pharmacy benefit manager (PBM) markets and vertical integration of insurers with PBMs. The assessment demonstrates low competition in PBM markets across the nation and high vertical integration as the largest PBMs share ownership with health insurers. The AMA analysis adds to growing concern over anticompetitive harm resulting from low competition and high vertical integration in the PBM industry. It comes on the heels of reports by the Federal Trade Commission and U.S. House Committee on Oversight and Accountability finding that a handful of PBMs have vast power and control over medication access and affordability. <Read More> 

First Guideline on Alzheimer’s Blood-Based Biomarker Tests Released – July 31, 2025 – An expert panel convened by the Alzheimer’s Association has released the first clinical guidelines to help clinicians choose the most appropriate blood-based biomarker (BBM) test to aid in the diagnosis of Alzheimer’s disease (AD). The evidence-based guideline recommends that tests with ≥ 90% sensitivity and specificity can serve as a substitute for amyloid PET or cerebrospinal fluid (CSF) biomarker testing. Tests with ≥ 90% sensitivity but only ≥ 75% specificity should be used as a triaging test. In this case, a negative result rules out AD pathology with high probability and a positive result should be confirmed with CSF or PET testing. <Read More>

This Year’s Prescription Drug Bills Aim to Reduce Consumer Costs – July 30, 2025 – More than 800 prescription drug access and affordability proposals were introduced across all 50 states, Washington, D.C., and the territories in this year’s legislative sessions. The more than 130 enacted bills included some familiar policies as well as some new ones. Lawmakers were looking for ways to hold costs down through pharmacy benefit manager (PBM) reform, with more than 40 states considering some 270 PBM-related bills. Several themes emerged, including  Prohibiting spread pricing. States may enter contractual arrangements with PBMs to administer state employee health plan and Medicaid prescription benefits. Spread pricing, which is a traditional PBM business model, is a contractual agreement where an insurer or employer pays a higher amount for a prescription drug than the PBM reimbursement to the pharmacy. The PBM then keeps a portion of the spread. Regulating agencies in several states have raised concerns over the spread PBMs retain. <Read More> 

Drugmaker Novo Nordisk Slashes Wegovy® Sales Forecasts, Blaming Compounding – July 29, 2025 – Novo Nordisk's shares plunged more than 20% Tuesday, after the company cut the forecast for its flagship obesity drug. Before the markets opened, the company announced that sales of its obesity medicine, Wegovy®, are expected to grow no more than 14% this year. That's down from its prediction of up to 21% on May 7. The company blames cheaper alternatives made by compounding pharmacies, which are allowed to make what are essentially copies of drugs when they're in short supply. Wegovy® and Ozempic®, a diabetes drug sometimes prescribed for weight loss, had been on the Food and Drug Administration's drug shortage list, paving the way for a boom in compounded versions. <Read More> 

Delinking Pharmacy Benefit Manager Compensation From Drug List Prices Could Unleash Major Savings – July 24, 2025 – Breaking the link between prescription drug list prices and compensation to middlemen like pharmacy benefit managers (PBMs) could cut a significant portion of the U.S.'s annual drug tab, finds a new analysis from the USC Schaeffer Center for Health Policy & Economics. The work is published in the journal Health Affairs Scholar. PBMs, who negotiate drug benefits on behalf of insurers and employers, are typically paid based on a percentage of a drug's list price before rebates and other discounts are applied. Federal and state policymakers have proposed delinking PBM compensation from list prices in response to evidence that PBMs often steer patients toward higher-priced drugs—even when cheaper alternatives are available—to boost their own profits. <Read More> 

New Biosimilars Metric Confirms Switching Efficacy – July 23, 2025 – Most patients who were switched from adalimumab (Humira®, AbbVie) to an interchangeable biosimilar experienced clinical success, with the vast majority remaining on a biosimilar three months after conversion, according to a study conducted at Brown University Health and presented in a poster (38-M) at the ASHP Pharmacy Futures 2025 meeting. The study used data from the center’s electronic health records and specialty pharmacy from Jan. 1, 2023, to June 1, 2024. The primary objective was to evaluate the rate of reversion to the reference product three months after a payor mandated a switch to a biosimilar. <Read More>

Specialty Pharmacies Can Dispense the Emotional Script to Support Patients – July 23, 2025 – Behind every specialty medication is a person facing uncertainty. As this market surges toward unprecedented growth over the next decade, specialty pharmacies are increasingly turning to automation to meet demand and manage costs. However, while efficiency metrics climb, something essential gets lost—the human experience. Specialty pharmacies that prioritize efficiency over empathy risk missing what matters most: meaningful connection during a critical moment in care. Research suggests that adherence may be influenced not only by logistical or clinical barriers but also by emotional and psychological factors, such as fear, uncertainty, and loneliness. <Read More> 

HHS and Private Health Insurers Team Up to Improve Prior Authorization Process – July 14, 2025 - Stakeholders from federal health agencies and leading payors have pledged to streamline the often burdensome prior authorization process that can lead to delays in treatment and poorer clinical outcomes. The new pledge, by America’s Health Insurance Plans (AHIP), a trade organization representing many health insurance companies, was at the center of a recent roundtable discussion that AHIP held with Health and Human Services Secretary Robert F. Kennedy Jr., and Mehmet Oz, MD, the administrator of the  Centers for Medicare & Medicaid Services (CMS). <Read More> 

340B in the News

HHS Announces New 340B Rebate Model Pilot Program – July 31, 2025 – The Department of Health and Human Services issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date. <Read More> 


Clinical Insights: July 10th, 2025

New Drug/Vaccine Approval

Ekterly® (sebetralstat) Tablets - New Drug Approval – July 7, 2025 - KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) announced that the U.S. Food and Drug Administration (FDA) has approved Ekterly® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Ekterly® is the first and only oral on-demand treatment for HAE. <Read More>

Lynozyfic™ (linvoseltamab-gcpt) Injection - New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic™, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. <Read More> 

Zegfrovy® (sunvozertinib) Tablets – New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy®, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. <Read More>

Harliku™ (nitisinone) Tablets - New Drug Approval – June 19, 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU. Launching in July 2025, Harliku™ will be the first and only FDA-approved treatment for AKU, an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys, and heart. <Read More> 

Yeztugo® (lenacapavir) Tablets and Injection - New Drug Approval – June 18, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD)  announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo® in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. <Read More> 

Andembry® (garadacimab-gxii) Injection - New Drug Approval – June 16, 2025 - Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) announces that the U.S. Food and Drug Administration (FDA) has approved Andembry® for immediate launch in the United States. Andembry® helps prevent attacks of hereditary angioedema (HAE). It is the first and only treatment targeting factor XIIa for prophylactic use to provide sustained protection from attacks of HAE in adult and pediatric patients aged 12 years and older. HAE occurs in about 1 in 50,000 people of any ethnic group. <Read More>

Zusduri™ (mitomycin) for Intravesical Solution - formerly UGN-102 - New Drug Approval – June 12, 2025 - UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,  announced the U.S. Food and Drug Administration (FDA) approved Zusduri™, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. Zusduri™ consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release RTGel® technology. ZUSDURI has been designed for potent tumor ablation. <Read More> 

Ibtroz™ (taletrectinib) Capsules - New Drug Approval – June 11, 2025 - Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved Ibtrozi™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). Ibtrozi™ is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. <Read More> 

Enflonsia™ (clesrovimab-cfor) Injection - New Drug Approval – June 9, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced the U.S. Food and Drug Administration (FDA) has approved Enflonsia™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. Enflonsia™ is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year. <Read More>

Widaplik™ (amlodipine, indapamide and telmisartan) Tablets - formerly GMRx2 - New Drug Approval – June 5, 2025 - George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease,  announces that the US Food and Drug Administration (FDA) has approved Widaplik™ (telmisartan, amlodipine and indapamide), formerly known as “GMRx2”, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. Widaplik™ is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Widaplik™, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability. <Read More> 

Xifyrm™ (meloxicam) Injection - New Drug Approval – June 5, 2025 - Azurity Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved Xifyrm™ (meloxicam injection) an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing. Xifyrm™  is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Xifyrm™ provides a non-opioid analgesic in a 30mg/mL vial for IV bolus injection over 15 seconds. Because of delayed onset of analgesia, Xifyrm™ alone is not recommended for use when rapid onset of analgesia is required. <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection - New Vaccine Approval – May 30, 2025 – Moderna, Inc. (NASDAQ:MRNA)  announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). <Read More> 

New Label Expansions

Gamifant® (emapalumab-lzsg) Injection – New Label Expansion – June 28, 2025 - Sobi® (STO: SOBI)  announced that the U.S. Food and Drug Administration (FDA) approved Gamifant® (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – June 26, 2025 -  Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. <Read More>

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – June 23, 2025 - Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. <Read More> 

Vizamyl™ (flutemetamol F 18) Injection – New Label Expansion – June 24, 2025 - GE HealthCare (Nasdaq: GEHC)  announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent Vizamyl™ (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl™ scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy. <Read More> 

Benlysta® (belimumab) Injection – New Label Expansion – June 24, 2025 - GSK plc (LSE/NYSE: GSK)  announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta® (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. With this approval, GSK is expanding choices for belimumab treatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. <Read More> 

Dupixent® (dupilumab) Injection – New Label Expansion – June 18, 2025 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. <Read More> 

Monjuvi® (tafasitamab-cxix) for Injection – New Label Expansion – June 18, 2025 - Incyte (Nasdaq:INCY)  announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). <Read More> 

Endari® (L-glutamine) Oral Powder – New Label Expansion – June 12, 2025 - Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced  that it has received Food and Drug Administration (FDA) approval for changes to the labelling of Endari® to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus. The additional information provides a more comprehensive characterization of Endari®, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari® with or without food. Endari® is approved in the U.S. and elsewhere to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – June 12, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. <Read More> 

Steqeyma® (ustekinumab-stba) Injection – New Label Expansion – June 12, 2025 - Celltrion, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, Steqeyma® now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. <Read More>  

Mavyret® (glecaprevir and pibrentasvir) Tablets and Oral Pellets – New Label Expansion – June 10, 2025 - AbbVie (NYSE: ABBV)  announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for Mavyret® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, Mavyret® is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. <Read More> 

Brukinsa® (zanubrutinib) Capsules and Tablets – New Label Expansion – June 3, 2025 - BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company,  announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Brukinsa® (zanubrutinib) for all five approved indications. Brukinsa® remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader. <Read More>

Nubeqa® (darolutamide) Tablets – New Label Expansion – June 3, 2025 - Bayer announced  that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) Nubeqa® (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with Nubeqa® plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001). <Read More> 

Xenoview® (xenon Xe 129 hyperpolarized) for Oral Inhalation – New Label Expansion – June 2, 2025 - Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration (“FDA”) has approved the Company’s Supplemental New Drug Application (“NDA”) to expand the indication of Xenoview®. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean’s total addressable market. <Read More> 

New Drug Shortage

July 8, 2025

July 1, 2025

June 27, 2025

June 26, 2025

June 24, 2025

June 18, 2025

Updated Drug Shortage

July 8, 2025

July 7, 2025

July 3, 2025

July 2, 2025

July 1, 2025

June 30, 2025

June 27, 2025

June 26, 2025

June 23, 2025

June 20, 2025

New Drug Recall and Safety Alerts

Cefazolin for Injection by Sandoz Inc. – New Voluntary Recall – June 27, 2025 - Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial. This single lot is being recalled due to a customer complaint indicating that four (4) Penicillin G Potassium for Injection, USP, 20 million Units labelled vials were incorrectly included in a carton (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. <Read More> 

Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs by Church & Dwight Co., Inc. – New Voluntary Recall – June 6, 2025 - Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. The products are being recalled due to potential microbial contamination identified as fungi in cotton swab components. Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions. To date, no serious adverse events associated with the affected product have been reported. <Read More> 

Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Amneal Pharmaceutical LLC – New Voluntary Recall – June 4, 2025 - Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition – July 1, 2025 – On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as part of the agencies’ implementation of President Donald Trump’s Executive Order No. 14273, titled “Lowering Drug Prices by Once Again Putting Americans First.” That order instructed the Department of Health and Human Services (HHS) secretary to conduct “joint public listening sessions with the [… DOJ], the Department of Commerce and the [FTC] and issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.” <Read More> 

Major Insurance Changes are Coming for Weight Loss Drugs. Here’s How it Could Affect Patients – July 1, 2025 – Last week, Tara Eacobacci had an appointment with her doctor that was devoted exclusively to the topic of health insurance. A major change to her prescription benefits meant the medication she was using to manage her weight – a treatment that had taken years of trial and error to get right – would no longer be covered by insurance. “I’m completely outraged,” Eacobacci said. “It’s not only causing me stress, but it is making me angry.” Starting Tuesday, CVS Caremark – a major pharmacy benefit manager that serves as a middleman for health insurers, large employers and other payers to manage their prescription drug plans – will stop covering Eli Lilly’s Zepbound, a blockbuster GLP-1 drug that has been approved by the U.S. Food and Drug Administration since November 2023 for chronic weight management in adults with obesity or who are overweight. <Read More> 

Congress Should Remove the Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It – June 27, 2025 – The Inflation Reduction Act (IRA) of 2022 allowed the Centers for Medicare and Medicaid Services to begin negotiating prices for certain prescription drugs in Medicare. For products to be eligible, they must meet several statutory requirements, including generating more than $200 million in annual Medicare sales (a threshold that increases annually with inflation), being approved by the Food and Drug Administration (FDA) for at least seven years (for small-molecule products) or 11 years (for biologic products), and not yet facing biosimilar or generic competition. In addition, Congress exempted from negotiation any drugs that are approved to treat a single rare disease. <Read More> 

Trump Vows to Cut 'The Best Deal' on Drug Prices. What to Expect – June 26, 2025 – Imagine forking out north of $25,000 for a month's supply of the drug keeping you alive. That's what many hepatitis C patients in the U.S. have had to pay for a 28-day course of Gilead Sciences' (GILD) Epclusa. Canadians paid 35% less for the same treatment, while Australians could buy nearly three months of the drug for roughly the same price…The Trump administration has a plan to change that. Dubbed the "Most Favored Nation" approach, the strategy aims to bring drug prices paid by Americans down to roughly the same level charged by pharma companies in other countries. President Donald Trump said he aims to get Americans "the best deal" on their prescriptions. <Read More> 

Generic Cancer Drugs Used Around the World Fail Quality Tests, Investigation Shows – June 25, 2025 – Vital chemotherapy drugs used around the world have failed quality tests, putting cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, an investigation by the Bureau of Investigative Journalism (TBIJ) reveals. The generic drugs in question form the backbone of treatment plans for numerous common cancers — including breast, ovarian, and leukemia. Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much of the active ingredient, create the risk of severe organ damage or even death. “Both scenarios are horrendous,” said one pharmacist. “It’s heartbreaking.” <Read More> 

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care – June 25, 2025 – Infliximab biosimilar initiation among pediatric patients with inflammatory bowel disease (IBD) rose gradually from 1% in 2018 to nearly 42% in 2023, with no consistent differences by age, race, or ethnicity and notable regional variation, according to a retrospective study. The analysis, published in Children, incorporated data from the ImproveCareNow (ICN) Network, a multicenter pediatric IBD quality improvement collaborative. Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend. In the US alone, IBD prevalence ranges from 100 to 200 per 100,000 children—amounting to an estimated 70,000 affected children—meaning that most pediatricians are likely to encounter and care for patients with IBD in their practice. <Read More> 

Abbvie Announces Head-to-Head Results Challenging Migraine Treatment Status Quo – June 24, 2025 – For the more than one billion people worldwide living with migraine, the path to effective prevention can feel like an obstacle course. While some migraine patients struggle to find a formal diagnosis, others must navigate a lengthy trial-and-error process with outdated therapies before they can access treatments that provide real relief. Despite migraine ranking as the second leading cause of disability globally, new patients must undergo a “step-therapy” approach, first trying older preventive medications such as anticonvulsants or antidepressants repurposed for migraine before being granted access to newer, more targeted therapies. <Read More> 

HRSA Announces Action to Lower Out-of-Pocket Costs for Life-Saving Medications at Health Centers Nationwide – June 24, 2025 – The Health Resources and Services Administration (HRSA announced new steps to lower out-of-pocket costs for life-saving medications. In alignment with President Trump’s Executive Order “Lowering Drug Prices by Putting Americans First,” HRSA has issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program…This new requirement aims to improve access and affordability for two of the most vital medications in emergency and chronic care: insulin, used by millions of Americans to manage diabetes, and injectable epinephrine, critical for the treatment of severe allergic reactions. The high costs of these medications have posed a growing challenge for underserved populations. <Read More> 

Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients is Crucial for Pharmacists – June 5, 2025 – Infliximab biosimilars (infliximab-abda and infliximab-dyyb) may delay treatment after patients switch from the reference product, suggesting a possible risk factor for flaring/loss of disease control, according to a study published in the Journal of Pharmacy Technology. Clinicians often treat rheumatic diseases like ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and uveitis, with the anti-tumor necrosis factor agent, infliximab. Over the past few years, the FDA approved 4 infliximab biosimilars. <Read More>

New ACG Guidelines Reflect ‘Tremendous’ Surge in Treatments for Crohn’s, Ulcerative Colitis – June 4, 2025 – The ACG has released new clinical guidelines for the management of ulcerative colitis and Crohn’s disease in adult patients. The guidelines, published in The American Journal of Gastroenterology, reflect numerous advances and new therapeutic options in the management of the two conditions, according to Gary R. Lichtenstein, MD, FACG, lead author of the CD guideline and vice chief of the division of gastroenterology and hepatology, development and philanthropy at Perelman School of Medicine at University of Pennsylvania. <Read More> 

340B in the News

340B Could Have a New Cop on The beat - Hospitals are Worried – July 2, 2025 – The Trump administration wants to move oversight of the controversial drug discount program to the CMS, which has a more aggressive history with 340B than its covered providers would prefer. The Trump administration is pushing significant changes to the healthcare status quo that it says will save money, improve oversight and make the $4.9 trillion sector more efficient. Many of the HHS’ most controversial actions since President Donald Trump took office in January have sparked widespread discussion or been litigated in court as the healthcare industry looks to adjust to the “move fast and break things” mentality of the new Washington. <Read More> 

Judge Rules Against J&J, for HHS and 340B Hospitals in Rebate Model Case – June 27, 2025 – A U.S. District Court for the District of Columbia judge June 27 ruled against Johnson & Johnson and sided with the Department of Health and Human Services and hospitals in a lawsuit brought by J&J challenging the government’s authority to reject J&J’s proposed 340B rebate model. “In sum, based on the plain and unambiguous language of the 340B statute, and supported by its purpose and history, HRSA has the authority to ‘provide’ for discounts, rebates, or both,” Judge Rudolph Contreras wrote. “This conclusion defeats J&J’s claim that HRSA lacked the authority to require prior approval of J&J’s rebate model.” <Read More> 

Cancer Patients are Overmedicated to Enrich Health Systems, Study Claims – June 23, 2025 – Are patients being prescribed more medications not for their health, but to generate profit? A new economic study published in The Journal of Health Economics reveals that cancer patients treated by physicians participating in the 340B Program receive more medications—including those outside clinical guidelines—without improvements in survival. The federal program, named after Section 340B of the Public Health Service Act, was created by Congress in 1992 to support hospitals and clinics serving low-income communities. It allows eligible entities to purchase outpatient drugs at steep discounts and sell at full prices, retaining the difference. The Affordable Care Act expanded eligibility criteria, accelerating the program’s growth. <Read More> 


Clinical Insights: July 10th, 2025

New Drug/Vaccine Approval

Ekterly® (sebetralstat) Tablets - New Drug Approval – July 7, 2025 - KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) announced that the U.S. Food and Drug Administration (FDA) has approved Ekterly® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Ekterly® is the first and only oral on-demand treatment for HAE. <Read More>

Lynozyfic™ (linvoseltamab-gcpt) Injection - New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic™, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. <Read More> 

Zegfrovy® (sunvozertinib) Tablets – New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy®, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. <Read More>

Harliku™ (nitisinone) Tablets - New Drug Approval – June 19, 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU. Launching in July 2025, Harliku™ will be the first and only FDA-approved treatment for AKU, an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys, and heart. <Read More> 

Yeztugo® (lenacapavir) Tablets and Injection - New Drug Approval – June 18, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD)  announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo® in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. <Read More> 

Andembry® (garadacimab-gxii) Injection - New Drug Approval – June 16, 2025 - Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) announces that the U.S. Food and Drug Administration (FDA) has approved Andembry® for immediate launch in the United States. Andembry® helps prevent attacks of hereditary angioedema (HAE). It is the first and only treatment targeting factor XIIa for prophylactic use to provide sustained protection from attacks of HAE in adult and pediatric patients aged 12 years and older. HAE occurs in about 1 in 50,000 people of any ethnic group. <Read More>

Zusduri™ (mitomycin) for Intravesical Solution - formerly UGN-102 - New Drug Approval – June 12, 2025 - UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,  announced the U.S. Food and Drug Administration (FDA) approved Zusduri™, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. Zusduri™ consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release RTGel® technology. ZUSDURI has been designed for potent tumor ablation. <Read More> 

Ibtroz™ (taletrectinib) Capsules - New Drug Approval – June 11, 2025 - Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved Ibtrozi™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). Ibtrozi™ is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. <Read More> 

Enflonsia™ (clesrovimab-cfor) Injection - New Drug Approval – June 9, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced the U.S. Food and Drug Administration (FDA) has approved Enflonsia™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. Enflonsia™ is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year. <Read More>

Widaplik™ (amlodipine, indapamide and telmisartan) Tablets - formerly GMRx2 - New Drug Approval – June 5, 2025 - George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease,  announces that the US Food and Drug Administration (FDA) has approved Widaplik™ (telmisartan, amlodipine and indapamide), formerly known as “GMRx2”, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. Widaplik™ is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Widaplik™, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability. <Read More> 

Xifyrm™ (meloxicam) Injection - New Drug Approval – June 5, 2025 - Azurity Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved Xifyrm™ (meloxicam injection) an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing. Xifyrm™  is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Xifyrm™ provides a non-opioid analgesic in a 30mg/mL vial for IV bolus injection over 15 seconds. Because of delayed onset of analgesia, Xifyrm™ alone is not recommended for use when rapid onset of analgesia is required. <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection - New Vaccine Approval – May 30, 2025 – Moderna, Inc. (NASDAQ:MRNA)  announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). <Read More> 

New Label Expansions

Gamifant® (emapalumab-lzsg) Injection – New Label Expansion – June 28, 2025 - Sobi® (STO: SOBI)  announced that the U.S. Food and Drug Administration (FDA) approved Gamifant® (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – June 26, 2025 -  Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. <Read More>

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – June 23, 2025 - Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. <Read More> 

Vizamyl™ (flutemetamol F 18) Injection – New Label Expansion – June 24, 2025 - GE HealthCare (Nasdaq: GEHC)  announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent Vizamyl™ (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl™ scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy. <Read More> 

Benlysta® (belimumab) Injection – New Label Expansion – June 24, 2025 - GSK plc (LSE/NYSE: GSK)  announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta® (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. With this approval, GSK is expanding choices for belimumab treatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. <Read More> 

Dupixent® (dupilumab) Injection – New Label Expansion – June 18, 2025 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. <Read More> 

Monjuvi® (tafasitamab-cxix) for Injection – New Label Expansion – June 18, 2025 - Incyte (Nasdaq:INCY)  announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). <Read More> 

Endari® (L-glutamine) Oral Powder – New Label Expansion – June 12, 2025 - Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced  that it has received Food and Drug Administration (FDA) approval for changes to the labelling of Endari® to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus. The additional information provides a more comprehensive characterization of Endari®, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari® with or without food. Endari® is approved in the U.S. and elsewhere to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – June 12, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. <Read More> 

Steqeyma® (ustekinumab-stba) Injection – New Label Expansion – June 12, 2025 - Celltrion, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, Steqeyma® now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. <Read More>  

Mavyret® (glecaprevir and pibrentasvir) Tablets and Oral Pellets – New Label Expansion – June 10, 2025 - AbbVie (NYSE: ABBV)  announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for Mavyret® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, Mavyret® is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. <Read More> 

Brukinsa® (zanubrutinib) Capsules and Tablets – New Label Expansion – June 3, 2025 - BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company,  announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Brukinsa® (zanubrutinib) for all five approved indications. Brukinsa® remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader. <Read More>

Nubeqa® (darolutamide) Tablets – New Label Expansion – June 3, 2025 - Bayer announced  that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) Nubeqa® (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with Nubeqa® plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001). <Read More> 

Xenoview® (xenon Xe 129 hyperpolarized) for Oral Inhalation – New Label Expansion – June 2, 2025 - Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration (“FDA”) has approved the Company’s Supplemental New Drug Application (“NDA”) to expand the indication of Xenoview®. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean’s total addressable market. <Read More> 

New Drug Shortage

July 8, 2025

July 1, 2025

June 27, 2025

June 26, 2025

June 24, 2025

June 18, 2025

Updated Drug Shortage

July 8, 2025

July 7, 2025

July 3, 2025

July 2, 2025

July 1, 2025

June 30, 2025

June 27, 2025

June 26, 2025

June 23, 2025

June 20, 2025

New Drug Recall and Safety Alerts

Cefazolin for Injection by Sandoz Inc. – New Voluntary Recall – June 27, 2025 - Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial. This single lot is being recalled due to a customer complaint indicating that four (4) Penicillin G Potassium for Injection, USP, 20 million Units labelled vials were incorrectly included in a carton (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. <Read More> 

Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs by Church & Dwight Co., Inc. – New Voluntary Recall – June 6, 2025 - Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. The products are being recalled due to potential microbial contamination identified as fungi in cotton swab components. Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions. To date, no serious adverse events associated with the affected product have been reported. <Read More> 

Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Amneal Pharmaceutical LLC – New Voluntary Recall – June 4, 2025 - Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition – July 1, 2025 – On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as part of the agencies’ implementation of President Donald Trump’s Executive Order No. 14273, titled “Lowering Drug Prices by Once Again Putting Americans First.” That order instructed the Department of Health and Human Services (HHS) secretary to conduct “joint public listening sessions with the [… DOJ], the Department of Commerce and the [FTC] and issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.” <Read More> 

Major Insurance Changes are Coming for Weight Loss Drugs. Here’s How it Could Affect Patients – July 1, 2025 – Last week, Tara Eacobacci had an appointment with her doctor that was devoted exclusively to the topic of health insurance. A major change to her prescription benefits meant the medication she was using to manage her weight – a treatment that had taken years of trial and error to get right – would no longer be covered by insurance. “I’m completely outraged,” Eacobacci said. “It’s not only causing me stress, but it is making me angry.” Starting Tuesday, CVS Caremark – a major pharmacy benefit manager that serves as a middleman for health insurers, large employers and other payers to manage their prescription drug plans – will stop covering Eli Lilly’s Zepbound, a blockbuster GLP-1 drug that has been approved by the U.S. Food and Drug Administration since November 2023 for chronic weight management in adults with obesity or who are overweight. <Read More> 

Congress Should Remove the Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It – June 27, 2025 – The Inflation Reduction Act (IRA) of 2022 allowed the Centers for Medicare and Medicaid Services to begin negotiating prices for certain prescription drugs in Medicare. For products to be eligible, they must meet several statutory requirements, including generating more than $200 million in annual Medicare sales (a threshold that increases annually with inflation), being approved by the Food and Drug Administration (FDA) for at least seven years (for small-molecule products) or 11 years (for biologic products), and not yet facing biosimilar or generic competition. In addition, Congress exempted from negotiation any drugs that are approved to treat a single rare disease. <Read More> 

Trump Vows to Cut 'The Best Deal' on Drug Prices. What to Expect – June 26, 2025 – Imagine forking out north of $25,000 for a month's supply of the drug keeping you alive. That's what many hepatitis C patients in the U.S. have had to pay for a 28-day course of Gilead Sciences' (GILD) Epclusa. Canadians paid 35% less for the same treatment, while Australians could buy nearly three months of the drug for roughly the same price…The Trump administration has a plan to change that. Dubbed the "Most Favored Nation" approach, the strategy aims to bring drug prices paid by Americans down to roughly the same level charged by pharma companies in other countries. President Donald Trump said he aims to get Americans "the best deal" on their prescriptions. <Read More> 

Generic Cancer Drugs Used Around the World Fail Quality Tests, Investigation Shows – June 25, 2025 – Vital chemotherapy drugs used around the world have failed quality tests, putting cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, an investigation by the Bureau of Investigative Journalism (TBIJ) reveals. The generic drugs in question form the backbone of treatment plans for numerous common cancers — including breast, ovarian, and leukemia. Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much of the active ingredient, create the risk of severe organ damage or even death. “Both scenarios are horrendous,” said one pharmacist. “It’s heartbreaking.” <Read More> 

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care – June 25, 2025 – Infliximab biosimilar initiation among pediatric patients with inflammatory bowel disease (IBD) rose gradually from 1% in 2018 to nearly 42% in 2023, with no consistent differences by age, race, or ethnicity and notable regional variation, according to a retrospective study. The analysis, published in Children, incorporated data from the ImproveCareNow (ICN) Network, a multicenter pediatric IBD quality improvement collaborative. Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend. In the US alone, IBD prevalence ranges from 100 to 200 per 100,000 children—amounting to an estimated 70,000 affected children—meaning that most pediatricians are likely to encounter and care for patients with IBD in their practice. <Read More> 

Abbvie Announces Head-to-Head Results Challenging Migraine Treatment Status Quo – June 24, 2025 – For the more than one billion people worldwide living with migraine, the path to effective prevention can feel like an obstacle course. While some migraine patients struggle to find a formal diagnosis, others must navigate a lengthy trial-and-error process with outdated therapies before they can access treatments that provide real relief. Despite migraine ranking as the second leading cause of disability globally, new patients must undergo a “step-therapy” approach, first trying older preventive medications such as anticonvulsants or antidepressants repurposed for migraine before being granted access to newer, more targeted therapies. <Read More> 

HRSA Announces Action to Lower Out-of-Pocket Costs for Life-Saving Medications at Health Centers Nationwide – June 24, 2025 – The Health Resources and Services Administration (HRSA announced new steps to lower out-of-pocket costs for life-saving medications. In alignment with President Trump’s Executive Order “Lowering Drug Prices by Putting Americans First,” HRSA has issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program…This new requirement aims to improve access and affordability for two of the most vital medications in emergency and chronic care: insulin, used by millions of Americans to manage diabetes, and injectable epinephrine, critical for the treatment of severe allergic reactions. The high costs of these medications have posed a growing challenge for underserved populations. <Read More> 

Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients is Crucial for Pharmacists – June 5, 2025 – Infliximab biosimilars (infliximab-abda and infliximab-dyyb) may delay treatment after patients switch from the reference product, suggesting a possible risk factor for flaring/loss of disease control, according to a study published in the Journal of Pharmacy Technology. Clinicians often treat rheumatic diseases like ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and uveitis, with the anti-tumor necrosis factor agent, infliximab. Over the past few years, the FDA approved 4 infliximab biosimilars. <Read More>

New ACG Guidelines Reflect ‘Tremendous’ Surge in Treatments for Crohn’s, Ulcerative Colitis – June 4, 2025 – The ACG has released new clinical guidelines for the management of ulcerative colitis and Crohn’s disease in adult patients. The guidelines, published in The American Journal of Gastroenterology, reflect numerous advances and new therapeutic options in the management of the two conditions, according to Gary R. Lichtenstein, MD, FACG, lead author of the CD guideline and vice chief of the division of gastroenterology and hepatology, development and philanthropy at Perelman School of Medicine at University of Pennsylvania. <Read More> 

340B in the News

340B Could Have a New Cop on The beat - Hospitals are Worried – July 2, 2025 – The Trump administration wants to move oversight of the controversial drug discount program to the CMS, which has a more aggressive history with 340B than its covered providers would prefer. The Trump administration is pushing significant changes to the healthcare status quo that it says will save money, improve oversight and make the $4.9 trillion sector more efficient. Many of the HHS’ most controversial actions since President Donald Trump took office in January have sparked widespread discussion or been litigated in court as the healthcare industry looks to adjust to the “move fast and break things” mentality of the new Washington. <Read More> 

Judge Rules Against J&J, for HHS and 340B Hospitals in Rebate Model Case – June 27, 2025 – A U.S. District Court for the District of Columbia judge June 27 ruled against Johnson & Johnson and sided with the Department of Health and Human Services and hospitals in a lawsuit brought by J&J challenging the government’s authority to reject J&J’s proposed 340B rebate model. “In sum, based on the plain and unambiguous language of the 340B statute, and supported by its purpose and history, HRSA has the authority to ‘provide’ for discounts, rebates, or both,” Judge Rudolph Contreras wrote. “This conclusion defeats J&J’s claim that HRSA lacked the authority to require prior approval of J&J’s rebate model.” <Read More> 

Cancer Patients are Overmedicated to Enrich Health Systems, Study Claims – June 23, 2025 – Are patients being prescribed more medications not for their health, but to generate profit? A new economic study published in The Journal of Health Economics reveals that cancer patients treated by physicians participating in the 340B Program receive more medications—including those outside clinical guidelines—without improvements in survival. The federal program, named after Section 340B of the Public Health Service Act, was created by Congress in 1992 to support hospitals and clinics serving low-income communities. It allows eligible entities to purchase outpatient drugs at steep discounts and sell at full prices, retaining the difference. The Affordable Care Act expanded eligibility criteria, accelerating the program’s growth. <Read More> 


Clinical Insights: July 10th, 2025

New Drug/Vaccine Approval

Ekterly® (sebetralstat) Tablets - New Drug Approval – July 7, 2025 - KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) announced that the U.S. Food and Drug Administration (FDA) has approved Ekterly® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Ekterly® is the first and only oral on-demand treatment for HAE. <Read More>

Lynozyfic™ (linvoseltamab-gcpt) Injection - New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic™, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. <Read More> 

Zegfrovy® (sunvozertinib) Tablets – New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy®, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. <Read More>

Harliku™ (nitisinone) Tablets - New Drug Approval – June 19, 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU. Launching in July 2025, Harliku™ will be the first and only FDA-approved treatment for AKU, an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys, and heart. <Read More> 

Yeztugo® (lenacapavir) Tablets and Injection - New Drug Approval – June 18, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD)  announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo® in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. <Read More> 

Andembry® (garadacimab-gxii) Injection - New Drug Approval – June 16, 2025 - Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) announces that the U.S. Food and Drug Administration (FDA) has approved Andembry® for immediate launch in the United States. Andembry® helps prevent attacks of hereditary angioedema (HAE). It is the first and only treatment targeting factor XIIa for prophylactic use to provide sustained protection from attacks of HAE in adult and pediatric patients aged 12 years and older. HAE occurs in about 1 in 50,000 people of any ethnic group. <Read More>

Zusduri™ (mitomycin) for Intravesical Solution - formerly UGN-102 - New Drug Approval – June 12, 2025 - UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,  announced the U.S. Food and Drug Administration (FDA) approved Zusduri™, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. Zusduri™ consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release RTGel® technology. ZUSDURI has been designed for potent tumor ablation. <Read More> 

Ibtroz™ (taletrectinib) Capsules - New Drug Approval – June 11, 2025 - Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved Ibtrozi™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). Ibtrozi™ is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. <Read More> 

Enflonsia™ (clesrovimab-cfor) Injection - New Drug Approval – June 9, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced the U.S. Food and Drug Administration (FDA) has approved Enflonsia™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. Enflonsia™ is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year. <Read More>

Widaplik™ (amlodipine, indapamide and telmisartan) Tablets - formerly GMRx2 - New Drug Approval – June 5, 2025 - George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease,  announces that the US Food and Drug Administration (FDA) has approved Widaplik™ (telmisartan, amlodipine and indapamide), formerly known as “GMRx2”, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. Widaplik™ is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Widaplik™, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability. <Read More> 

Xifyrm™ (meloxicam) Injection - New Drug Approval – June 5, 2025 - Azurity Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved Xifyrm™ (meloxicam injection) an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing. Xifyrm™  is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Xifyrm™ provides a non-opioid analgesic in a 30mg/mL vial for IV bolus injection over 15 seconds. Because of delayed onset of analgesia, Xifyrm™ alone is not recommended for use when rapid onset of analgesia is required. <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection - New Vaccine Approval – May 30, 2025 – Moderna, Inc. (NASDAQ:MRNA)  announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). <Read More> 

New Label Expansions

Gamifant® (emapalumab-lzsg) Injection – New Label Expansion – June 28, 2025 - Sobi® (STO: SOBI)  announced that the U.S. Food and Drug Administration (FDA) approved Gamifant® (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – June 26, 2025 -  Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. <Read More>

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – June 23, 2025 - Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. <Read More> 

Vizamyl™ (flutemetamol F 18) Injection – New Label Expansion – June 24, 2025 - GE HealthCare (Nasdaq: GEHC)  announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent Vizamyl™ (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl™ scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy. <Read More> 

Benlysta® (belimumab) Injection – New Label Expansion – June 24, 2025 - GSK plc (LSE/NYSE: GSK)  announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta® (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. With this approval, GSK is expanding choices for belimumab treatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. <Read More> 

Dupixent® (dupilumab) Injection – New Label Expansion – June 18, 2025 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. <Read More> 

Monjuvi® (tafasitamab-cxix) for Injection – New Label Expansion – June 18, 2025 - Incyte (Nasdaq:INCY)  announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). <Read More> 

Endari® (L-glutamine) Oral Powder – New Label Expansion – June 12, 2025 - Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced  that it has received Food and Drug Administration (FDA) approval for changes to the labelling of Endari® to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus. The additional information provides a more comprehensive characterization of Endari®, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari® with or without food. Endari® is approved in the U.S. and elsewhere to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – June 12, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. <Read More> 

Steqeyma® (ustekinumab-stba) Injection – New Label Expansion – June 12, 2025 - Celltrion, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, Steqeyma® now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. <Read More>  

Mavyret® (glecaprevir and pibrentasvir) Tablets and Oral Pellets – New Label Expansion – June 10, 2025 - AbbVie (NYSE: ABBV)  announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for Mavyret® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, Mavyret® is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. <Read More> 

Brukinsa® (zanubrutinib) Capsules and Tablets – New Label Expansion – June 3, 2025 - BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company,  announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Brukinsa® (zanubrutinib) for all five approved indications. Brukinsa® remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader. <Read More>

Nubeqa® (darolutamide) Tablets – New Label Expansion – June 3, 2025 - Bayer announced  that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) Nubeqa® (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with Nubeqa® plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001). <Read More> 

Xenoview® (xenon Xe 129 hyperpolarized) for Oral Inhalation – New Label Expansion – June 2, 2025 - Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration (“FDA”) has approved the Company’s Supplemental New Drug Application (“NDA”) to expand the indication of Xenoview®. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean’s total addressable market. <Read More> 

New Drug Shortage

July 8, 2025

July 1, 2025

June 27, 2025

June 26, 2025

June 24, 2025

June 18, 2025

Updated Drug Shortage

July 8, 2025

July 7, 2025

July 3, 2025

July 2, 2025

July 1, 2025

June 30, 2025

June 27, 2025

June 26, 2025

June 23, 2025

June 20, 2025

New Drug Recall and Safety Alerts

Cefazolin for Injection by Sandoz Inc. – New Voluntary Recall – June 27, 2025 - Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial. This single lot is being recalled due to a customer complaint indicating that four (4) Penicillin G Potassium for Injection, USP, 20 million Units labelled vials were incorrectly included in a carton (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. <Read More> 

Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs by Church & Dwight Co., Inc. – New Voluntary Recall – June 6, 2025 - Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. The products are being recalled due to potential microbial contamination identified as fungi in cotton swab components. Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions. To date, no serious adverse events associated with the affected product have been reported. <Read More> 

Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Amneal Pharmaceutical LLC – New Voluntary Recall – June 4, 2025 - Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition – July 1, 2025 – On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as part of the agencies’ implementation of President Donald Trump’s Executive Order No. 14273, titled “Lowering Drug Prices by Once Again Putting Americans First.” That order instructed the Department of Health and Human Services (HHS) secretary to conduct “joint public listening sessions with the [… DOJ], the Department of Commerce and the [FTC] and issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.” <Read More> 

Major Insurance Changes are Coming for Weight Loss Drugs. Here’s How it Could Affect Patients – July 1, 2025 – Last week, Tara Eacobacci had an appointment with her doctor that was devoted exclusively to the topic of health insurance. A major change to her prescription benefits meant the medication she was using to manage her weight – a treatment that had taken years of trial and error to get right – would no longer be covered by insurance. “I’m completely outraged,” Eacobacci said. “It’s not only causing me stress, but it is making me angry.” Starting Tuesday, CVS Caremark – a major pharmacy benefit manager that serves as a middleman for health insurers, large employers and other payers to manage their prescription drug plans – will stop covering Eli Lilly’s Zepbound, a blockbuster GLP-1 drug that has been approved by the U.S. Food and Drug Administration since November 2023 for chronic weight management in adults with obesity or who are overweight. <Read More> 

Congress Should Remove the Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It – June 27, 2025 – The Inflation Reduction Act (IRA) of 2022 allowed the Centers for Medicare and Medicaid Services to begin negotiating prices for certain prescription drugs in Medicare. For products to be eligible, they must meet several statutory requirements, including generating more than $200 million in annual Medicare sales (a threshold that increases annually with inflation), being approved by the Food and Drug Administration (FDA) for at least seven years (for small-molecule products) or 11 years (for biologic products), and not yet facing biosimilar or generic competition. In addition, Congress exempted from negotiation any drugs that are approved to treat a single rare disease. <Read More> 

Trump Vows to Cut 'The Best Deal' on Drug Prices. What to Expect – June 26, 2025 – Imagine forking out north of $25,000 for a month's supply of the drug keeping you alive. That's what many hepatitis C patients in the U.S. have had to pay for a 28-day course of Gilead Sciences' (GILD) Epclusa. Canadians paid 35% less for the same treatment, while Australians could buy nearly three months of the drug for roughly the same price…The Trump administration has a plan to change that. Dubbed the "Most Favored Nation" approach, the strategy aims to bring drug prices paid by Americans down to roughly the same level charged by pharma companies in other countries. President Donald Trump said he aims to get Americans "the best deal" on their prescriptions. <Read More> 

Generic Cancer Drugs Used Around the World Fail Quality Tests, Investigation Shows – June 25, 2025 – Vital chemotherapy drugs used around the world have failed quality tests, putting cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, an investigation by the Bureau of Investigative Journalism (TBIJ) reveals. The generic drugs in question form the backbone of treatment plans for numerous common cancers — including breast, ovarian, and leukemia. Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much of the active ingredient, create the risk of severe organ damage or even death. “Both scenarios are horrendous,” said one pharmacist. “It’s heartbreaking.” <Read More> 

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care – June 25, 2025 – Infliximab biosimilar initiation among pediatric patients with inflammatory bowel disease (IBD) rose gradually from 1% in 2018 to nearly 42% in 2023, with no consistent differences by age, race, or ethnicity and notable regional variation, according to a retrospective study. The analysis, published in Children, incorporated data from the ImproveCareNow (ICN) Network, a multicenter pediatric IBD quality improvement collaborative. Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend. In the US alone, IBD prevalence ranges from 100 to 200 per 100,000 children—amounting to an estimated 70,000 affected children—meaning that most pediatricians are likely to encounter and care for patients with IBD in their practice. <Read More> 

Abbvie Announces Head-to-Head Results Challenging Migraine Treatment Status Quo – June 24, 2025 – For the more than one billion people worldwide living with migraine, the path to effective prevention can feel like an obstacle course. While some migraine patients struggle to find a formal diagnosis, others must navigate a lengthy trial-and-error process with outdated therapies before they can access treatments that provide real relief. Despite migraine ranking as the second leading cause of disability globally, new patients must undergo a “step-therapy” approach, first trying older preventive medications such as anticonvulsants or antidepressants repurposed for migraine before being granted access to newer, more targeted therapies. <Read More> 

HRSA Announces Action to Lower Out-of-Pocket Costs for Life-Saving Medications at Health Centers Nationwide – June 24, 2025 – The Health Resources and Services Administration (HRSA announced new steps to lower out-of-pocket costs for life-saving medications. In alignment with President Trump’s Executive Order “Lowering Drug Prices by Putting Americans First,” HRSA has issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program…This new requirement aims to improve access and affordability for two of the most vital medications in emergency and chronic care: insulin, used by millions of Americans to manage diabetes, and injectable epinephrine, critical for the treatment of severe allergic reactions. The high costs of these medications have posed a growing challenge for underserved populations. <Read More> 

Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients is Crucial for Pharmacists – June 5, 2025 – Infliximab biosimilars (infliximab-abda and infliximab-dyyb) may delay treatment after patients switch from the reference product, suggesting a possible risk factor for flaring/loss of disease control, according to a study published in the Journal of Pharmacy Technology. Clinicians often treat rheumatic diseases like ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and uveitis, with the anti-tumor necrosis factor agent, infliximab. Over the past few years, the FDA approved 4 infliximab biosimilars. <Read More>

New ACG Guidelines Reflect ‘Tremendous’ Surge in Treatments for Crohn’s, Ulcerative Colitis – June 4, 2025 – The ACG has released new clinical guidelines for the management of ulcerative colitis and Crohn’s disease in adult patients. The guidelines, published in The American Journal of Gastroenterology, reflect numerous advances and new therapeutic options in the management of the two conditions, according to Gary R. Lichtenstein, MD, FACG, lead author of the CD guideline and vice chief of the division of gastroenterology and hepatology, development and philanthropy at Perelman School of Medicine at University of Pennsylvania. <Read More> 

340B in the News

340B Could Have a New Cop on The beat - Hospitals are Worried – July 2, 2025 – The Trump administration wants to move oversight of the controversial drug discount program to the CMS, which has a more aggressive history with 340B than its covered providers would prefer. The Trump administration is pushing significant changes to the healthcare status quo that it says will save money, improve oversight and make the $4.9 trillion sector more efficient. Many of the HHS’ most controversial actions since President Donald Trump took office in January have sparked widespread discussion or been litigated in court as the healthcare industry looks to adjust to the “move fast and break things” mentality of the new Washington. <Read More> 

Judge Rules Against J&J, for HHS and 340B Hospitals in Rebate Model Case – June 27, 2025 – A U.S. District Court for the District of Columbia judge June 27 ruled against Johnson & Johnson and sided with the Department of Health and Human Services and hospitals in a lawsuit brought by J&J challenging the government’s authority to reject J&J’s proposed 340B rebate model. “In sum, based on the plain and unambiguous language of the 340B statute, and supported by its purpose and history, HRSA has the authority to ‘provide’ for discounts, rebates, or both,” Judge Rudolph Contreras wrote. “This conclusion defeats J&J’s claim that HRSA lacked the authority to require prior approval of J&J’s rebate model.” <Read More> 

Cancer Patients are Overmedicated to Enrich Health Systems, Study Claims – June 23, 2025 – Are patients being prescribed more medications not for their health, but to generate profit? A new economic study published in The Journal of Health Economics reveals that cancer patients treated by physicians participating in the 340B Program receive more medications—including those outside clinical guidelines—without improvements in survival. The federal program, named after Section 340B of the Public Health Service Act, was created by Congress in 1992 to support hospitals and clinics serving low-income communities. It allows eligible entities to purchase outpatient drugs at steep discounts and sell at full prices, retaining the difference. The Affordable Care Act expanded eligibility criteria, accelerating the program’s growth. <Read More> 


Clinical Insights: June 4th, 2025

New Drug/Vaccine Approval

Tryptyr® (acoltremon) Ophthalmic Solution – New Drug Approval – May 28, 2025 - Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, announced the U.S. Food and Drug Administration (FDA) has approved Tryptyr® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED). Tryptyr® is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation. <Read More>

Yutrepia™ (treprostinil) Inhalation Powder - formerly LIQ861 – New Drug Approval – May 23, 2025 - Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced that the U.S. Food and Drug Administration (FDA) has approved Yutrepia™ (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. Yutrepia™ is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary PRINT™ technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension - formerly Novavax COVID-19 Vaccine – New Vaccine Approval – May 16, 2025 - Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid™ for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).1 Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi. <Read More> 

Emrelis™ (telisotuzumab vedotin-tllv) Lyophilized Powder for Injection - formerly Teliso-V – New Drug Approval – May 14, 2025 - AbbVie (NYSE: ABBV) announced that Emrelis™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test. <Read More> 

Brekiya® (dihydroergotamine mesylate) Injection – New Drug Approval – May 14, 2025 - Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. <Read More> 

Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) Capsules/Tablets – New Drug Approval – May 8, 2025 - The Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki™ Fakzynja™ Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. Efficacy was evaluated in RAMP-201 (NCT04625270), an open-label, multicenter trial that included 57 adult patients with measurable KRAS-mutated recurrent LGSOC. <Read More>  

Atzumi™ (dihydroergotamine mesylate) Nasal Powder - formerly STS101 – New Drug Approval – April 30, 2025 - Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™ (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi™ was previously known as STS101. <Read More> 

Imaavy™ (nipocalimab-aahu) Injection – New Drug Approval – April 29, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Imaavy™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG (adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive). <Read More> 

Zevaskyn™ (prademagene zamikeracel) Gene-Modified Cellular Sheets – New Drug Approval – April 28, 2025 - Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the U.S. Food and Drug Administration (FDA) has approved Zevaskyn™ (pronounced as ‘ZEE-vah-skin’) (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease. There is no cure for RDEB and Zevaskyn™ is the only FDA-approved product to treat RDEB wounds with a single application. <Read More> 

New Label Expansions

Nucala® (mepolizumab) Injection – New Label Expansion – May 22, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. FDA’s approval was based on data from the positive MATINEE and METREX phase III trials. Across these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype. <Read More> 

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – May 22, 2025 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Zoryve® (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. Zoryve® foam is a once-daily, steroid-free topical and is now widely available as a treatment for plaque psoriasis. <Read More>

Susvimo® (ranibizumab) Injection for Intravitreal Use via Ocular Implant – New Label Expansion – May 21, 2025 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. <Read More> 

Yuflyma® (adalimumab-aaty) Injection – New Label Expansion – May 21, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. With this approval, Yuflyma® is now fully interchangeable with the reference product, Humira® (adalimumab), across all marketed dosage forms and strengths. Yuflyma® is a high-concentration, citrate-free biosimilar to Humira®, approved for multiple inflammatory indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older. <Read More> 

Hadlima™ (adalimumab-bwwd) Injection – New Label Expansion – May 21, 2025 – Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has designated the Hadlima™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira® (adalimumab). These interchangeability designations follow the interchangeability designation received for the HADLIMA low-concentration (40 mg/0.8 mL) prefilled syringe and single-dose vial in June 2024. With these additional interchangeability designations, Hadlima™ is now interchangeable with all presentations of the reference product. An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws. <Read More> 

Jivi® (antihemophilic factor [recombinant] PEGylated-aucl) Injection – New Label Expansion – May 19, 2025 – Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi®, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency). The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi’s safety and efficacy in children aged 7 to under 12 years with severe hemophilia A. <Read More> 

Zynyz® (retifanlimab-dlwr) Injection – New Label Expansion – May 15, 2025 – Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz® (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, the FDA granted approval for Zynyz® as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. <Read More>

Welireg® (belzutifan) Tablets – New Label Expansion – May 14, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved Welireg® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Pheochromocytoma and paraganglioma are rare tumors that come from the same tissue, but pheochromocytoma form in the adrenal gland and paraganglioma form outside the adrenal gland. These tumors can be caused by certain genetic syndromes or mutations. The approval is based on data from the single-arm LITESPARK-015 clinical trial, where the primary endpoint was objective response rate (ORR). <Read More> 

Selarsdi™ (ustekinumab-aekn) Injection – New Label Expansion – April 30, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) announced that the U.S. Food and Drug Administration (FDA) has approved Selarsdi™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). As of April 30, 2025, Selarsdi™ is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. <Read More> 

Otulfi® (ustekinumab-aauz) Injection – New Label Expansion – April 30, 2025 – Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab). Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status. <Read More> 

Rinvoq® (upadacitinib) Extended-Release Tablets – New Label Expansion – April 28, 2025 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). This comes after the European Commission recently granted marketing authorization of Rinvoq® for the treatment of GCA in adult patients. The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission. <Read More> 

New Drug Shortage

May 30, 2025

May 28, 2025

May 23, 2025

May 19, 2025

May 14, 2025

Updated Drug Shortage

May 28, 2025

May 23, 2025

May 22, 2025

May 21, 2025

May 20, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Tasigna® (nilotinib) Capsules – New Generic Approval – May 27, 2025 – Apotex Corp. announced the launch of nilotinib capsules, a generic version of Tasigna®, in the United States, with 180 days of exclusivity. Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. It is also indicated for adults and pediatric patients with chronic or accelerated phase Ph+ CML with resistance or intolerance to prior therapy, demonstrating higher efficacy compared with other available treatments. <Read More> 

Starjemza® (ustekinumab-hmny) Injection – New Stelara® Biosimilar Approval – May 22, 2025 - Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Starjemza® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. Starjemza® is Bio-Thera’s third FDA approved product. <Read More> 

Clinical and Pharmacy News

Chronic Musculoskeletal Pain: Recommendations for Nondrug Treatment – June 1, 2025 – First-line recommendations for chronic musculoskeletal pain include cognitive behavioral therapy, multicomponent self-management interventions, and, for specific areas, exercise and psychological therapies. Other treatments may be effective, but quality of evidence issues preclude making recommendations about those treatments. It is important for care to be patient-centered and use a shared decision-making model between providers and individuals experiencing chronic pain. <Read More> 

Medical Errors are Still Harming Patients. AI Could Help Change That – May 25, 2025 – John Wiederspan is well aware of how things can go wrong in the high-pressure, high-stakes environment of an operating room. “During situations such as trauma or a patient doing poorly, there’s a real rush to try and get emergency drugs into the patient as fast as possible,” said Wiederspan, a nurse anesthetist at UW Medicine in Seattle. “And that’s when mistakes can occur, when you’re flustered, your adrenaline’s rushing, you’re drawing up drugs and you’re trying to push them.” <Read More> 

New Migraine Recommendations Make Treatment Options More Accessible – May 21, 2025 – More than 15% of adults in the United States (that’s roughly 41 million Americans) experience migraine attacks. This neurologic condition—which may include blinding pain, nausea, a loss or distortion of vision, and a heightened sensitivity to light and sound—contributes to lost work and healthcare costs. But until recently, there were no official, evidenced-based recommendations for primary care physicians on how to treat these types of episodic (occurring less than 15 times a month) headaches. Now for the first time the American College of Physicians (ACP) has issued new treatment guidelines based on an extensive and independent review… <Read More> 

Closing the Affordability Gap: How Automation is Advancing Biosimilar Adoption – May 19, 2025 – Millions of Americans are currently facing a difficult choice: either pay for expensive biologic medications or ration doses to afford basic needs. Cost-related nonadherence (CRN) is where patients either skip or delay their medication due to cost concerns, a challenge that is widespread throughout the U.S. The financial burden is even greater for those managing multiple chronic conditions, where prescription costs can quickly add up to unmanageable amounts. Despite the financial strain, biosimilars—lower-cost alternatives to expensive biologics—remain vastly underutilized. <Read More> 

FDA Biosimilar Approvals set for Record-Breaking Year Amid US Pricing Reforms – May 16, 2025 – 2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA approved 19 biosimilars last year, a sharp jump from the five greenlit by the agency in 2023. GlobalData’s Bio/Pharmaceutical Outsourcing Report notes that momentum for biosimilars is set to accelerate. A total of 18 biologics will lose patent protection in 2025, up from 14 in 2024. This includes blockbuster products such as Amgen’s Prolia® (denosumab) and Roche’s Perjeta® (pertuzumab). <Read More> 

Trump's Drug Pricing Order Delivers Blow to Pharmacy Benefit Managers – May 12, 2025 -President Donald Trump on Monday delivered a blow to the private-sector middlemen who negotiate U.S. drug prices in his executive order on drug pricing, saying he would cut them out as part of a goal to bring the U.S. in line with other countries. The news drove their shares down even as pharmaceutical stocks rose in investor relief about the broad order. "We're going to cut out the middlemen and facilitate the direct sale of drugs at the most favored nation price, directly to the American citizen," Trump said during a press conference. <Read More> 

340B in the News

Unpacking the 25% HHS Budget Cut Proposed by the Trump Administration – June 2, 2025 – A recent budget document prepared by the White House is giving new clarity over how the Department of Health and Human Services (HHS) could operate for fiscal year 2026. The document closely mirrored other budgetary insights from earlier this year. Under the wishes of President Donald Trump’s staff, the department’s discretionary budget would be nearly $95 billion, a $32 billion decrease amounting to a one-fourth slashing. Congress has final authority on submitting the budget, so some proposals may not be carried out, but the newest budget outline gives the clearest sense yet of the administration’s priorities. Committees on the Hill are expected to begin marking up the budget this week. <Read More> 

Future of 340B Rebate Models Hinges on Regulatory Decision Point – May 20, 2025 – A federal judge has sided with a US government agency in a simmering battle over a federal drug discount plan, ruling that it has the right to first approve a controversial proposal by several pharmaceutical companies to use rebates – instead of upfront discounts – when selling medicines to hospitals. Meanwhile, the Trump administration is expected to take a more definitive move next month. The ruling came after some companies sought to change payment terms for transactions conducted as part of the 340B Drug Discount Program, which was created to make sure vulnerable patients have access to medicines. <Read More> 

Judge Shuts Down Drugmakers’ 340B Rebate Plans, for now – May 19, 2025 – Drugmakers have to continue paying hospitals upfront discounts for drugs in the 340B program — at least in the near term — after a federal court ruled late last week against major manufacturers that wanted to issue rebates for 340B drugs instead. However, the D.C. district court didn’t entirely rule out drugmakers’ paying after-the-fact rebates in the future, instead determining that the companies would need to get prior approval from the Health Resources and Services Administration, the HHS subagency that oversees 340B. It also directed HRSA to reconsider a rebate plan from Sanofi that regulators had denied. <Read More> 

Clinical Insights: June 4th, 2025

New Drug/Vaccine Approval

Tryptyr® (acoltremon) Ophthalmic Solution – New Drug Approval – May 28, 2025 - Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, announced the U.S. Food and Drug Administration (FDA) has approved Tryptyr® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED). Tryptyr® is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation. <Read More>

Yutrepia™ (treprostinil) Inhalation Powder - formerly LIQ861 – New Drug Approval – May 23, 2025 - Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced that the U.S. Food and Drug Administration (FDA) has approved Yutrepia™ (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. Yutrepia™ is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary PRINT™ technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension - formerly Novavax COVID-19 Vaccine – New Vaccine Approval – May 16, 2025 - Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid™ for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).1 Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi. <Read More> 

Emrelis™ (telisotuzumab vedotin-tllv) Lyophilized Powder for Injection - formerly Teliso-V – New Drug Approval – May 14, 2025 - AbbVie (NYSE: ABBV) announced that Emrelis™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test. <Read More> 

Brekiya® (dihydroergotamine mesylate) Injection – New Drug Approval – May 14, 2025 - Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. <Read More> 

Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) Capsules/Tablets – New Drug Approval – May 8, 2025 - The Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki™ Fakzynja™ Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. Efficacy was evaluated in RAMP-201 (NCT04625270), an open-label, multicenter trial that included 57 adult patients with measurable KRAS-mutated recurrent LGSOC. <Read More>  

Atzumi™ (dihydroergotamine mesylate) Nasal Powder - formerly STS101 – New Drug Approval – April 30, 2025 - Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™ (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi™ was previously known as STS101. <Read More> 

Imaavy™ (nipocalimab-aahu) Injection – New Drug Approval – April 29, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Imaavy™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG (adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive). <Read More> 

Zevaskyn™ (prademagene zamikeracel) Gene-Modified Cellular Sheets – New Drug Approval – April 28, 2025 - Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the U.S. Food and Drug Administration (FDA) has approved Zevaskyn™ (pronounced as ‘ZEE-vah-skin’) (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease. There is no cure for RDEB and Zevaskyn™ is the only FDA-approved product to treat RDEB wounds with a single application. <Read More> 

New Label Expansions

Nucala® (mepolizumab) Injection – New Label Expansion – May 22, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. FDA’s approval was based on data from the positive MATINEE and METREX phase III trials. Across these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype. <Read More> 

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – May 22, 2025 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Zoryve® (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. Zoryve® foam is a once-daily, steroid-free topical and is now widely available as a treatment for plaque psoriasis. <Read More>

Susvimo® (ranibizumab) Injection for Intravitreal Use via Ocular Implant – New Label Expansion – May 21, 2025 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. <Read More> 

Yuflyma® (adalimumab-aaty) Injection – New Label Expansion – May 21, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. With this approval, Yuflyma® is now fully interchangeable with the reference product, Humira® (adalimumab), across all marketed dosage forms and strengths. Yuflyma® is a high-concentration, citrate-free biosimilar to Humira®, approved for multiple inflammatory indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older. <Read More> 

Hadlima™ (adalimumab-bwwd) Injection – New Label Expansion – May 21, 2025 – Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has designated the Hadlima™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira® (adalimumab). These interchangeability designations follow the interchangeability designation received for the HADLIMA low-concentration (40 mg/0.8 mL) prefilled syringe and single-dose vial in June 2024. With these additional interchangeability designations, Hadlima™ is now interchangeable with all presentations of the reference product. An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws. <Read More> 

Jivi® (antihemophilic factor [recombinant] PEGylated-aucl) Injection – New Label Expansion – May 19, 2025 – Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi®, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency). The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi’s safety and efficacy in children aged 7 to under 12 years with severe hemophilia A. <Read More> 

Zynyz® (retifanlimab-dlwr) Injection – New Label Expansion – May 15, 2025 – Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz® (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, the FDA granted approval for Zynyz® as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. <Read More>

Welireg® (belzutifan) Tablets – New Label Expansion – May 14, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved Welireg® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Pheochromocytoma and paraganglioma are rare tumors that come from the same tissue, but pheochromocytoma form in the adrenal gland and paraganglioma form outside the adrenal gland. These tumors can be caused by certain genetic syndromes or mutations. The approval is based on data from the single-arm LITESPARK-015 clinical trial, where the primary endpoint was objective response rate (ORR). <Read More> 

Selarsdi™ (ustekinumab-aekn) Injection – New Label Expansion – April 30, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) announced that the U.S. Food and Drug Administration (FDA) has approved Selarsdi™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). As of April 30, 2025, Selarsdi™ is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. <Read More> 

Otulfi® (ustekinumab-aauz) Injection – New Label Expansion – April 30, 2025 – Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab). Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status. <Read More> 

Rinvoq® (upadacitinib) Extended-Release Tablets – New Label Expansion – April 28, 2025 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). This comes after the European Commission recently granted marketing authorization of Rinvoq® for the treatment of GCA in adult patients. The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission. <Read More> 

New Drug Shortage

May 30, 2025

May 28, 2025

May 23, 2025

May 19, 2025

May 14, 2025

Updated Drug Shortage

May 28, 2025

May 23, 2025

May 22, 2025

May 21, 2025

May 20, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Tasigna® (nilotinib) Capsules – New Generic Approval – May 27, 2025 – Apotex Corp. announced the launch of nilotinib capsules, a generic version of Tasigna®, in the United States, with 180 days of exclusivity. Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. It is also indicated for adults and pediatric patients with chronic or accelerated phase Ph+ CML with resistance or intolerance to prior therapy, demonstrating higher efficacy compared with other available treatments. <Read More> 

Starjemza® (ustekinumab-hmny) Injection – New Stelara® Biosimilar Approval – May 22, 2025 - Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Starjemza® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. Starjemza® is Bio-Thera’s third FDA approved product. <Read More> 

Clinical and Pharmacy News

Chronic Musculoskeletal Pain: Recommendations for Nondrug Treatment – June 1, 2025 – First-line recommendations for chronic musculoskeletal pain include cognitive behavioral therapy, multicomponent self-management interventions, and, for specific areas, exercise and psychological therapies. Other treatments may be effective, but quality of evidence issues preclude making recommendations about those treatments. It is important for care to be patient-centered and use a shared decision-making model between providers and individuals experiencing chronic pain. <Read More> 

Medical Errors are Still Harming Patients. AI Could Help Change That – May 25, 2025 – John Wiederspan is well aware of how things can go wrong in the high-pressure, high-stakes environment of an operating room. “During situations such as trauma or a patient doing poorly, there’s a real rush to try and get emergency drugs into the patient as fast as possible,” said Wiederspan, a nurse anesthetist at UW Medicine in Seattle. “And that’s when mistakes can occur, when you’re flustered, your adrenaline’s rushing, you’re drawing up drugs and you’re trying to push them.” <Read More> 

New Migraine Recommendations Make Treatment Options More Accessible – May 21, 2025 – More than 15% of adults in the United States (that’s roughly 41 million Americans) experience migraine attacks. This neurologic condition—which may include blinding pain, nausea, a loss or distortion of vision, and a heightened sensitivity to light and sound—contributes to lost work and healthcare costs. But until recently, there were no official, evidenced-based recommendations for primary care physicians on how to treat these types of episodic (occurring less than 15 times a month) headaches. Now for the first time the American College of Physicians (ACP) has issued new treatment guidelines based on an extensive and independent review… <Read More> 

Closing the Affordability Gap: How Automation is Advancing Biosimilar Adoption – May 19, 2025 – Millions of Americans are currently facing a difficult choice: either pay for expensive biologic medications or ration doses to afford basic needs. Cost-related nonadherence (CRN) is where patients either skip or delay their medication due to cost concerns, a challenge that is widespread throughout the U.S. The financial burden is even greater for those managing multiple chronic conditions, where prescription costs can quickly add up to unmanageable amounts. Despite the financial strain, biosimilars—lower-cost alternatives to expensive biologics—remain vastly underutilized. <Read More> 

FDA Biosimilar Approvals set for Record-Breaking Year Amid US Pricing Reforms – May 16, 2025 – 2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA approved 19 biosimilars last year, a sharp jump from the five greenlit by the agency in 2023. GlobalData’s Bio/Pharmaceutical Outsourcing Report notes that momentum for biosimilars is set to accelerate. A total of 18 biologics will lose patent protection in 2025, up from 14 in 2024. This includes blockbuster products such as Amgen’s Prolia® (denosumab) and Roche’s Perjeta® (pertuzumab). <Read More> 

Trump's Drug Pricing Order Delivers Blow to Pharmacy Benefit Managers – May 12, 2025 -President Donald Trump on Monday delivered a blow to the private-sector middlemen who negotiate U.S. drug prices in his executive order on drug pricing, saying he would cut them out as part of a goal to bring the U.S. in line with other countries. The news drove their shares down even as pharmaceutical stocks rose in investor relief about the broad order. "We're going to cut out the middlemen and facilitate the direct sale of drugs at the most favored nation price, directly to the American citizen," Trump said during a press conference. <Read More> 

340B in the News

Unpacking the 25% HHS Budget Cut Proposed by the Trump Administration – June 2, 2025 – A recent budget document prepared by the White House is giving new clarity over how the Department of Health and Human Services (HHS) could operate for fiscal year 2026. The document closely mirrored other budgetary insights from earlier this year. Under the wishes of President Donald Trump’s staff, the department’s discretionary budget would be nearly $95 billion, a $32 billion decrease amounting to a one-fourth slashing. Congress has final authority on submitting the budget, so some proposals may not be carried out, but the newest budget outline gives the clearest sense yet of the administration’s priorities. Committees on the Hill are expected to begin marking up the budget this week. <Read More> 

Future of 340B Rebate Models Hinges on Regulatory Decision Point – May 20, 2025 – A federal judge has sided with a US government agency in a simmering battle over a federal drug discount plan, ruling that it has the right to first approve a controversial proposal by several pharmaceutical companies to use rebates – instead of upfront discounts – when selling medicines to hospitals. Meanwhile, the Trump administration is expected to take a more definitive move next month. The ruling came after some companies sought to change payment terms for transactions conducted as part of the 340B Drug Discount Program, which was created to make sure vulnerable patients have access to medicines. <Read More> 

Judge Shuts Down Drugmakers’ 340B Rebate Plans, for now – May 19, 2025 – Drugmakers have to continue paying hospitals upfront discounts for drugs in the 340B program — at least in the near term — after a federal court ruled late last week against major manufacturers that wanted to issue rebates for 340B drugs instead. However, the D.C. district court didn’t entirely rule out drugmakers’ paying after-the-fact rebates in the future, instead determining that the companies would need to get prior approval from the Health Resources and Services Administration, the HHS subagency that oversees 340B. It also directed HRSA to reconsider a rebate plan from Sanofi that regulators had denied. <Read More> 

Clinical Insights: June 4th, 2025

New Drug/Vaccine Approval

Tryptyr® (acoltremon) Ophthalmic Solution – New Drug Approval – May 28, 2025 - Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, announced the U.S. Food and Drug Administration (FDA) has approved Tryptyr® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED). Tryptyr® is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation. <Read More>

Yutrepia™ (treprostinil) Inhalation Powder - formerly LIQ861 – New Drug Approval – May 23, 2025 - Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced that the U.S. Food and Drug Administration (FDA) has approved Yutrepia™ (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. Yutrepia™ is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary PRINT™ technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension - formerly Novavax COVID-19 Vaccine – New Vaccine Approval – May 16, 2025 - Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid™ for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).1 Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi. <Read More> 

Emrelis™ (telisotuzumab vedotin-tllv) Lyophilized Powder for Injection - formerly Teliso-V – New Drug Approval – May 14, 2025 - AbbVie (NYSE: ABBV) announced that Emrelis™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test. <Read More> 

Brekiya® (dihydroergotamine mesylate) Injection – New Drug Approval – May 14, 2025 - Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. <Read More> 

Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) Capsules/Tablets – New Drug Approval – May 8, 2025 - The Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki™ Fakzynja™ Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. Efficacy was evaluated in RAMP-201 (NCT04625270), an open-label, multicenter trial that included 57 adult patients with measurable KRAS-mutated recurrent LGSOC. <Read More>  

Atzumi™ (dihydroergotamine mesylate) Nasal Powder - formerly STS101 – New Drug Approval – April 30, 2025 - Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™ (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi™ was previously known as STS101. <Read More> 

Imaavy™ (nipocalimab-aahu) Injection – New Drug Approval – April 29, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Imaavy™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG (adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive). <Read More> 

Zevaskyn™ (prademagene zamikeracel) Gene-Modified Cellular Sheets – New Drug Approval – April 28, 2025 - Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the U.S. Food and Drug Administration (FDA) has approved Zevaskyn™ (pronounced as ‘ZEE-vah-skin’) (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease. There is no cure for RDEB and Zevaskyn™ is the only FDA-approved product to treat RDEB wounds with a single application. <Read More> 

New Label Expansions

Nucala® (mepolizumab) Injection – New Label Expansion – May 22, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. FDA’s approval was based on data from the positive MATINEE and METREX phase III trials. Across these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype. <Read More> 

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – May 22, 2025 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Zoryve® (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. Zoryve® foam is a once-daily, steroid-free topical and is now widely available as a treatment for plaque psoriasis. <Read More>

Susvimo® (ranibizumab) Injection for Intravitreal Use via Ocular Implant – New Label Expansion – May 21, 2025 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. <Read More> 

Yuflyma® (adalimumab-aaty) Injection – New Label Expansion – May 21, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. With this approval, Yuflyma® is now fully interchangeable with the reference product, Humira® (adalimumab), across all marketed dosage forms and strengths. Yuflyma® is a high-concentration, citrate-free biosimilar to Humira®, approved for multiple inflammatory indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older. <Read More> 

Hadlima™ (adalimumab-bwwd) Injection – New Label Expansion – May 21, 2025 – Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has designated the Hadlima™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira® (adalimumab). These interchangeability designations follow the interchangeability designation received for the HADLIMA low-concentration (40 mg/0.8 mL) prefilled syringe and single-dose vial in June 2024. With these additional interchangeability designations, Hadlima™ is now interchangeable with all presentations of the reference product. An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws. <Read More> 

Jivi® (antihemophilic factor [recombinant] PEGylated-aucl) Injection – New Label Expansion – May 19, 2025 – Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi®, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency). The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi’s safety and efficacy in children aged 7 to under 12 years with severe hemophilia A. <Read More> 

Zynyz® (retifanlimab-dlwr) Injection – New Label Expansion – May 15, 2025 – Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz® (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, the FDA granted approval for Zynyz® as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. <Read More>

Welireg® (belzutifan) Tablets – New Label Expansion – May 14, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved Welireg® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Pheochromocytoma and paraganglioma are rare tumors that come from the same tissue, but pheochromocytoma form in the adrenal gland and paraganglioma form outside the adrenal gland. These tumors can be caused by certain genetic syndromes or mutations. The approval is based on data from the single-arm LITESPARK-015 clinical trial, where the primary endpoint was objective response rate (ORR). <Read More> 

Selarsdi™ (ustekinumab-aekn) Injection – New Label Expansion – April 30, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) announced that the U.S. Food and Drug Administration (FDA) has approved Selarsdi™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). As of April 30, 2025, Selarsdi™ is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. <Read More> 

Otulfi® (ustekinumab-aauz) Injection – New Label Expansion – April 30, 2025 – Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab). Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status. <Read More> 

Rinvoq® (upadacitinib) Extended-Release Tablets – New Label Expansion – April 28, 2025 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). This comes after the European Commission recently granted marketing authorization of Rinvoq® for the treatment of GCA in adult patients. The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission. <Read More> 

New Drug Shortage

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Updated Drug Shortage

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New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Tasigna® (nilotinib) Capsules – New Generic Approval – May 27, 2025 – Apotex Corp. announced the launch of nilotinib capsules, a generic version of Tasigna®, in the United States, with 180 days of exclusivity. Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. It is also indicated for adults and pediatric patients with chronic or accelerated phase Ph+ CML with resistance or intolerance to prior therapy, demonstrating higher efficacy compared with other available treatments. <Read More> 

Starjemza® (ustekinumab-hmny) Injection – New Stelara® Biosimilar Approval – May 22, 2025 - Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Starjemza® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. Starjemza® is Bio-Thera’s third FDA approved product. <Read More> 

Clinical and Pharmacy News

Chronic Musculoskeletal Pain: Recommendations for Nondrug Treatment – June 1, 2025 – First-line recommendations for chronic musculoskeletal pain include cognitive behavioral therapy, multicomponent self-management interventions, and, for specific areas, exercise and psychological therapies. Other treatments may be effective, but quality of evidence issues preclude making recommendations about those treatments. It is important for care to be patient-centered and use a shared decision-making model between providers and individuals experiencing chronic pain. <Read More> 

Medical Errors are Still Harming Patients. AI Could Help Change That – May 25, 2025 – John Wiederspan is well aware of how things can go wrong in the high-pressure, high-stakes environment of an operating room. “During situations such as trauma or a patient doing poorly, there’s a real rush to try and get emergency drugs into the patient as fast as possible,” said Wiederspan, a nurse anesthetist at UW Medicine in Seattle. “And that’s when mistakes can occur, when you’re flustered, your adrenaline’s rushing, you’re drawing up drugs and you’re trying to push them.” <Read More> 

New Migraine Recommendations Make Treatment Options More Accessible – May 21, 2025 – More than 15% of adults in the United States (that’s roughly 41 million Americans) experience migraine attacks. This neurologic condition—which may include blinding pain, nausea, a loss or distortion of vision, and a heightened sensitivity to light and sound—contributes to lost work and healthcare costs. But until recently, there were no official, evidenced-based recommendations for primary care physicians on how to treat these types of episodic (occurring less than 15 times a month) headaches. Now for the first time the American College of Physicians (ACP) has issued new treatment guidelines based on an extensive and independent review… <Read More> 

Closing the Affordability Gap: How Automation is Advancing Biosimilar Adoption – May 19, 2025 – Millions of Americans are currently facing a difficult choice: either pay for expensive biologic medications or ration doses to afford basic needs. Cost-related nonadherence (CRN) is where patients either skip or delay their medication due to cost concerns, a challenge that is widespread throughout the U.S. The financial burden is even greater for those managing multiple chronic conditions, where prescription costs can quickly add up to unmanageable amounts. Despite the financial strain, biosimilars—lower-cost alternatives to expensive biologics—remain vastly underutilized. <Read More> 

FDA Biosimilar Approvals set for Record-Breaking Year Amid US Pricing Reforms – May 16, 2025 – 2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA approved 19 biosimilars last year, a sharp jump from the five greenlit by the agency in 2023. GlobalData’s Bio/Pharmaceutical Outsourcing Report notes that momentum for biosimilars is set to accelerate. A total of 18 biologics will lose patent protection in 2025, up from 14 in 2024. This includes blockbuster products such as Amgen’s Prolia® (denosumab) and Roche’s Perjeta® (pertuzumab). <Read More> 

Trump's Drug Pricing Order Delivers Blow to Pharmacy Benefit Managers – May 12, 2025 -President Donald Trump on Monday delivered a blow to the private-sector middlemen who negotiate U.S. drug prices in his executive order on drug pricing, saying he would cut them out as part of a goal to bring the U.S. in line with other countries. The news drove their shares down even as pharmaceutical stocks rose in investor relief about the broad order. "We're going to cut out the middlemen and facilitate the direct sale of drugs at the most favored nation price, directly to the American citizen," Trump said during a press conference. <Read More> 

340B in the News

Unpacking the 25% HHS Budget Cut Proposed by the Trump Administration – June 2, 2025 – A recent budget document prepared by the White House is giving new clarity over how the Department of Health and Human Services (HHS) could operate for fiscal year 2026. The document closely mirrored other budgetary insights from earlier this year. Under the wishes of President Donald Trump’s staff, the department’s discretionary budget would be nearly $95 billion, a $32 billion decrease amounting to a one-fourth slashing. Congress has final authority on submitting the budget, so some proposals may not be carried out, but the newest budget outline gives the clearest sense yet of the administration’s priorities. Committees on the Hill are expected to begin marking up the budget this week. <Read More> 

Future of 340B Rebate Models Hinges on Regulatory Decision Point – May 20, 2025 – A federal judge has sided with a US government agency in a simmering battle over a federal drug discount plan, ruling that it has the right to first approve a controversial proposal by several pharmaceutical companies to use rebates – instead of upfront discounts – when selling medicines to hospitals. Meanwhile, the Trump administration is expected to take a more definitive move next month. The ruling came after some companies sought to change payment terms for transactions conducted as part of the 340B Drug Discount Program, which was created to make sure vulnerable patients have access to medicines. <Read More> 

Judge Shuts Down Drugmakers’ 340B Rebate Plans, for now – May 19, 2025 – Drugmakers have to continue paying hospitals upfront discounts for drugs in the 340B program — at least in the near term — after a federal court ruled late last week against major manufacturers that wanted to issue rebates for 340B drugs instead. However, the D.C. district court didn’t entirely rule out drugmakers’ paying after-the-fact rebates in the future, instead determining that the companies would need to get prior approval from the Health Resources and Services Administration, the HHS subagency that oversees 340B. It also directed HRSA to reconsider a rebate plan from Sanofi that regulators had denied. <Read More> 

Ready to get started?

The Pillr Health team is here to empower your 340B program, and beyond. Reach out at the link below.

Ready to get started?

The Pillr Health team is here to empower your 340B program, and beyond. Reach out at the link below.