Clinical Insights: July 24, 2024

Clinical Insights: August 22, 2024

Clinical Insights: August 7, 2024

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

Tecelra™ (afamitresgene autoleucel) Suspension for Intravenous Infusion – New Drug Approval – August 1, 2024 - The Food and Drug Administration granted accelerated approval to afamitresgene autoleucel (Tecelra™, Adaptimmune, LLC), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. <Read More> Erzofri® (paliperidone palmitate) Extended-Release Injectable Suspension – New Drug Approval – July 26, 2024 - Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Erzofri® (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. <Read More> Zunveyl® (benzgalantamine) Delayed-Release Tablets - formerly ALPHA-1062 – New Drug Approval – July 26, 2024 – Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announces that the U.S. Food and Drug Administration (FDA) has granted approval for Zunveyl® (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease. <Read More> Leqselvi™ (deuruxolitinib phosphate) Tablets – New Drug Approval – July 25, 2024 – Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) announced that the U.S. Food and Drug Administration (FDA) approved Leqselvi™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. <Read More> Femlyv™ (ethinyl estradiol and norethindrone acetate) Orally Disintegrating Tablets – New Drug Approval – July 22, 2024 – The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  The FDA approved Femlyv™ (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv™, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968. <Read More>

New Indication/Dosage/Formulation Approval

Jemperli® (dostarlimab-gxly) Injection – New Label Expansion – August 1, 2024 – The Food and Drug Administration approved dostarlimab-gxly (Jemperli®, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer (EC). Dostarlimab-gxly previously was approved with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent EC that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). <Read More> Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – July 30, 2024 – Johnson & Johnson (NYSE:JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). Patients will have the opportunity to receive this Darzalex Faspro®-based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes. <Read More> Palforzia® (Peanut (Arachis hypogaea) Allergen Powder-dnfp) Capsules and Sachets – New Label Expansion – July 26, 2024 – The U.S. Food and Drug Administration approved Palforzia® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia® may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. Those who take Palforzia® must continue to avoid peanuts in their diets. <Read More> Livmarli® (maralixibat) Oral Solution – New Label Expansion – July 25, 2024 – Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Livmarli® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as the higher concentration formulation of Livmarli® evaluated in the MARCH Phase 3 study. <Read More>  Brineura® (cerliponase alfa) Injection – New Label Expansion – July 24, 2024 – BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Brineura® (cerliponase alfa) to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Previously, Brineura® was indicated in symptomatic children 3 years of age and older with late infantile CLN2 disease. This expanded indication now includes children of all ages with CLN2 disease, regardless of whether they are symptomatic or presymptomatic. <Read More> Xembify® (immune globulin subcutaneous, human - klhw) Injection – New Label Expansion – July 18, 2024 – Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, announced that the United States Food and Drug Administration (FDA) has approved an expanded label for Xembify®, the company’s 20% subcutaneous immunoglobulin (SCIg), to include treatment-naïve patients with primary humoral immunodeficiencies (PI). Xembify® becomes the first 20% SCIg with this extended label, allowing patients to begin SCIg therapy without first having intravenous administration. <Read More> Voquezna® (vonoprazan) Tablets – New Label Expansion – July 17, 2024 – Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced the U.S. Food and Drug Administration (FDA) has approved Voquezna® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals suffering from frequent heartburn. This is the third FDA approval for Voquezna®, which is also approved to treat all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and in combination with antibiotics for the eradication of Helicobacter pylori (H. pylori) infection. <Read More>

New Drug Shortage

August 05, 2024

July 26, 2024

July 22, 2024

Updated Drug Shortage

August 02, 2024

July 31, 2024

July 30, 2024

July 25, 2024

July 24, 2024

New Drug Recall and Safety Alerts

Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets by Aurobindo Pharma USA, Inc. – New Voluntary Recall – July 24, 2024 – Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through Amazon to known within the US market due to the product missing the manufacturer label. <Read More> Acetaminophen Injection, 1000mg/100mL, (10mg/mL) Bags by Hikma Pharmaceuticals USA Inc. – New Voluntary Recall – July 22, 2024 - Hikma Pharmaceuticals PLC (Hikma, Group), announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recalled due to the potential presence of a bag labelled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). <Read More>

New Generic/Biosimilar Approval and Launch

Epysqli® (eculizumab-aagh) Injection – New Biosimilar Approval – July 19, 2024 – Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli® (eculizumab-aagh) as a biosimilar to Soliris® (eculizumab). Epysqli® has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Epysqli® is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). <Read More>

Clinical and Pharmacy News

Many Online Pharmacies Selling Weight Loss Products Illegally: Study – August 3, 2024 – Many online pharmacies that are selling semaglutide, the main ingredient in weight loss drugs such as Ozempic® and Wegovy®, are doing so illegally, according to new research. The study, released Friday in the journal JAMA Network Open, found that when researchers used search engines to try and find “websites advertising semaglutide without a prescription” in the summer of last year, 42.27 percent of the online pharmacies that came up “belonged to illegal pharmacy operations.” <Read More> Preoperative, Pharmacist-Led Medication Reconciliation Improves Safety – July 30, 2024 – Pharmacist-led medication reconciliation, implemented prior to a patient’s admittance to the hospital for surgery, improved safety and outcomes. Studies have shown that medical errors involving prescriptions in the hospital setting often stem from medical history obtained at admission. Causes include missing information and discrepancies in the patient’s medication history. Many of these studies examined post-admission-led medication reconciliation (MR) by pharmacists; however, little, if any, information is available on the impact of pre-admission pharmacist intervention in MR. <Read More> BRCA1/2: Why Men Should be Screened for the “Breast Cancer Gene” – July 25, 2024 –New research shows that men can carry mutations in the BRCA1 and BRCA2 genes that increase their risk of several cancers, but new national guidelines are helping to educate patients… These risks for men traditionally have been under-recognized, but newly developed national screening guidelines offer hope for identifying the cancer risk of BRCA mutations in men through genetic testing and tailored cancer screening, according to an article published from Fred Hutch Cancer Center and University of Washington scientists in the journal JAMA Oncology. <Read More> Industrial Policy to Reduce Prescription Generic Drug Shortages – July 23, 2024 – Shortages of prescription generic drugs, which account for nearly 90 percent of prescriptions, are frequent and can last for several months or even years. A recent study shows that from 2017 to 2021, the U.S. Food and Drug Administration (FDA) received 731 manufacturer “supply chain issue reports,” which are meant to identify shortages that could affect the national supply of an important prescription drug. Of those, 113 drugs had a “meaningful” shortage, defined as a reduction of 33 percent or more in the quantity supplied within six months of the issuer report compared with the preceding three months. A substantial majority of these shortages were for drugs where generics are available, a majority lasted for more than a year, and the median age of the drug was 17 years. <Read More> Early Aggressive Treatment May Work Best in Newly Diagnosed Multiple Sclerosis – July 23, 2024 – For many years, physicians have been treating multiple sclerosis (MS) with an "escalation" approach. This has typically meant starting patients on a mild-moderately effective disease-modifying therapy (DMT) until symptoms and/or imaging reveal disease breakthrough activity. At that point, treatment is often escalated to a higher-efficacy DMT. Over time, however, this traditional treatment paradigm seems to be less entrenched as international treatment guidelines continue to vary on their recommendations for using specific DMTs. Data from a wide variety of clinical studies have shown that newer, higher-efficacy DMTs can have a positive long-term impact when started earlier in the disease course. <Read More> Comer: Pharmacy Benefit Managers Must be Held Accountable for Role in Rising Drug Prices –July 23, 2024 – House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) delivered opening remarks at a full committee hearing titled “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability.” In his opening statement, Chairman Comer detailed how the House Oversight Committee has obtained over 140,000 pages of documents and communications exposing Pharmacy Benefit Managers’ (PBMs) anticompetitive policies and their role in rising drug prices. The information, outlined in an Oversight Committee report, shows how the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—have prioritized deliberate pricing tactics to line their own pockets, which have increased prescription drug costs, hurt independent pharmacies, and harmed patient care. He concluded that the House Oversight Committee will continue to seek bipartisan solutions to hold PBMs accountable for undermining the health of all Americans. <Read More>

340B in the News

SET Enterprises Launches 340B Covered Entity Suspicious Purchase Identification Service for Pharmaceutical and Biological Manufacturers – August 2, 2024 – SET Enterprises ( set-enterprises.com ), a leading independent management consulting firm serving the government pricing compliance needs of life sciences manufacturers, announced the launch of SPI340B℠. This new service offering identifies specific 340B covered entities that exhibit suspicious purchasing patterns that suggest the entire volume of products purchased from pharmaceutical and biotechnology manufacturers may not be dispensed solely to eligible patients of the covered entity. 340B entities are required to dispense covered outpatient drugs only to a person who is a patient of the entity and are specifically prohibited from reselling the drug to another entity. Reselling discounted 340B drugs or dispensing to a non-patient is known as diversion. <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> 

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> 

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> 

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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> 

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Clinical Insights: May 1st, 2025

New Drug/Vaccine Approval

Penpulimab-kcqx Injection – New Drug Approval – April 23, 2025 – The Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Efficacy of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 (NCT04974398), a randomized, double-blind, multi-center trial in 291 patients with recurrent or metastatic NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease. <Read More>

Vanrafia® (atrasentan) Tablets – New Drug Approval – April 2, 2025 – Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. Vanrafia® is a once-daily, non-steroidal, oral treatment that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. <Read More> 

New Indication / Dosage / Formulation Approval

Camzyos® (mavacamten) Capsules – New Label Expansion – April 17, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has updated the U.S. Prescribing Information for Camzyos® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules), simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications. Camzyos® is the first and only FDA-approved cardiac myosin inhibitor for the treatment of adults with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. <Read More> 

Dupixent® (dupilumab) Injection – New Label Expansion – April 17, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. <Read More> 

Valtoco® (diazepam) Nasal Spray – New Label Expansion – April 16, 2025 – Neurelis, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco® (diazepam nasal spray) for short-term treatment of seizure clusters (also known as “acute repetitive seizures”) that are different from a person’s normal seizure pattern in people 2 years of age and older. Valtoco® is a proprietary formulation which utilizes an absorption enhancement technology, Intravail®, to enable the noninvasive, enhanced intranasal delivery of diazepam.  The intranasal formulation of Neurelis’ Valtoco® was previously recognized by the FDA as clinically superior to the rectal gel formulation of diazepam resulting in its orphan drug exclusivity designation. <Read More>

Isturisa® (osilodrostat) Tablets – New Label Expansion – April 15, 2025 – Recordati announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa® (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This is an expansion of the previous indication for the treatment of patients with Cushing’s disease, which is a sub-type of Cushing’s syndrome. <Read More> 

Livmarli® (maralixibat) Oral Solution and Tablets – New Label Expansion – April 14, 2025 – Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Livmarli® (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). <Read More>

Opdivo® (nivolumab) Injection – New Label Expansion – April 11, 2025 – The Food and Drug Administration approved nivolumab (Opdivo®, Bristol Myers Squibb Company) with ipilimumab (Yervoy®, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Efficacy was evaluated in CHECKMATE-9DW (NCT04039607), a randomized (1:1), open-label trial in 668 adults with unresectable or metastatic HCC. Patients had histologically confirmed HCC, Child Pugh Class A, ECOG performance status 0 or 1, and no prior systemic therapy for advanced disease. <Read More> 

Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection – New Label Expansion – April 10, 2025 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject Vyvgart® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). <Read More> 

Vitrakvi® (larotrectinib) Capsules and Oral Solution – New Label Expansion – April 9, 2025 – Bayer announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Vitrakvi® (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Vitrakvi® has demonstrated clinically meaningful and durable responses across a range of NTRK fusion-positive solid tumors. Vitrakvi® was first granted accelerated approval by FDA in November 2018. <Read More> 

Opdivo® (nivolumab) Injection – New Label Expansion – April 8, 2025 – the Food and Drug Administration approved nivolumab (Opdivo®, Bristol Myers Squibb Company) with ipilimumab (Yervoy®, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan. <Read More> 

Yuflyma® (adalimumab-aaty) Injection – New Label Expansion – April 7, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated Yuflyma® (adalimumab-aaty), as an interchangeable biosimilar to Humira® (adalimumab). Yuflyma® is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications. <Read More>  

Uplizna® (inebilizumab-cdon) Injection – New Label Expansion – April 3, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine's potential to benefit patients. <Read More>  

Tryvio™ (aprocitentan) Tablets – New Label Expansion – April 2, 2025 – Idorsia Ltd (SIX: IDIA) announced that – effective immediately – the US FDA has fully released Tryvio™ (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement. Tryvio™ is Idorsia’s dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. The US FDA has determined that a REMS is no longer necessary to ensure the benefits of Tryvio™ outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information. The FDA have therefore removed the requirement to minimize the burden on the healthcare delivery system of complying with the REMS. <Read More> 

Jynneos® (smallpox and mpox vaccine) Injection – New Label Expansion – March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of Jynneos® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. <Read More>

New Drug Shortage

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New Drug Recall and Safety Alerts

Ropivacaine Hydrochloride Injection, USP 500mg/100mL by Amneal Pharmaceutical LLC - New Voluntary Recall – April 18, 2025 - Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag. <Read More>

New Generic/Biosimilar Approval and Launch

Jobevne™ (bevacizumab-nwgd) Injection – New Avastin® Biosimilar Approval – April 9, 2025 – Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. Jobevne™, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). Jobevne™ is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. <Read More> 

Clinical and Pharmacy News

Eli Lilly Sues Companies Selling Alternative Versions of its Weight Loss Drug – April 23, 2025 – Eli Lilly, the drugmaker behind the blockbuster weight loss drug Zepboundâ, is suing four telehealth companies for allegedly selling illegal copies of the drug made by compounding pharmacies. Compounded drugs aren't generics. Rather, they are essentially copies that are allowed to be made by special pharmacies called compounding pharmacies during drug shortages. Tirzepatide, the active ingredient in Lilly's Zepboundâ and Mounjaroâ for Type 2 diabetes, was in shortage for two years until Dec. 19, 2024. The U.S. Food and Drug Administration required an end to making the copies by mid-March, but pharmacies could sell stock already produced until it ran out or expired. And compounders can generally make custom drugs for patients with a doctor's prescription as they do for patients with allergies to certain preservatives in medications, for example. <Read More> 

Rethinking Psoriasis Severity for Better Treatment Access – April 21, 2025 – Psoriasis (PsO) is a chronic inflammatory skin condition that affects nearly 8 million adults in the U.S. and significantly impacts both physical and mental health. Early and aggressive treatment can greatly improve symptom relief, but many people with moderate to severe psoriasis do not receive this due to rigid treatment criteria. A new study is challenging the way doctors determine who qualifies for systemic treatment—and it could lead to better care for patients whose disease goes underestimated. <Read More> 

Machine Learning Improves Fluid Overload Prediction in ICU – April 17, 2025 – A machine learning (ML)-identified medication cluster more accurately predicts fluid overload (FO) in ICU patients than traditional models, according to a new study from the MRC-ICU Investigator Team, a multicenter group of researchers focused on data-driven, optimal pharmacotherapeutic care for critical care patients (Pharmacotherapy 2025;45[2]:76-86). This result also suggests that artificial intelligence could be used to identify other medication-related predictive risk factors in critical care that may be less straightforward than FO, the investigators noted. <Read More> 

State Bans PBMs From Owning Pharmacies – April 17, 2025 – Arkansas Gov. Sarah Huckabee Sanders (R) signed legislation Wednesday prohibiting pharmacy benefit managers from owning or operating pharmacies, becoming the first state to enact such a restriction. The measure comes as other states are considering restrictions on pharmacy benefit managers, which run prescription drug coverage for big clients that include health insurers and employers that provide coverage. Supporters of the restrictions have said pharmacy benefit managers are forcing independent pharmacies, especially in rural areas, out of business. <Read More>

Leaked HHS Budget Reveals 30% Cuts, Elimination of Many Core Services – April 17, 2025 – A 64-page leaked budget proposal from the U.S. Department of Health and Human Services (HHS) reveals more than $40 billion in cuts to various programs, including the total elimination of some and the consolidation of others. The unfinalized plan, first reported by the Washington Post, shows that the proposed cuts extend beyond the termination of diversity, equity and inclusion (DEI) initiatives. Services related to teen pregnancy prevention, lead safety, rural development, energy assistance, and Head Start have all been completely zeroed out in the proposed budget, along with research initiatives focused on Lyme disease, autism, and firearm-related deaths. <Read More> 

Trump Order Seeks Changes to Medicare Drug Price Negotiation Program, PBM Reform – April 16, 2025 – President Donald Trump has signed an executive order looking to modify the Inflation Reduction Act’s (IRA's) drug price negotiation program, among other policy shifts. The wide-ranging order requires the Department of Health and Human Services to seek public comment on the drug price negotiation program, which effectively requires manufacturers to agree to lower prices for certain drugs, for potential changes in upcoming years. “The guidance shall improve the transparency of the Medicare drug price negotiation program, prioritize the selection of prescription drugs with high costs to the Medicare program and minimize any negative impacts of the maximum fair price on pharmaceutical innovation within the United States,” the order reads. <Read More> 

IL-6 Promising Biomarker for Diagnosing Sepsis Early – April 16, 2025 – Because it rises early after an infectious insult, interleukin-6 (IL-6) may be an effective biomarker for predicting sepsis in high-risk patients, including neonates, children and pregnant women, said Seán O. Whelan, MB, BAO, BCh, BSc, MSc, MRCPI, at ESCMID Global 2025, in Vienna (abstract O0177). Managing sepsis is a race against time, so the clinical diagnosis of sepsis is always a challenge, but especially in these three groups, because physiologic changes can obscure its early signs, explained Dr. Whelan, a clinical microbiology trainee in Dublin. Specific challenges include “difficulties with consensus definitions for what sepsis means in each of these populations; the presence of confounding co-pathologies that closely mimic sepsis and may be far more common than sepsis, which are difficult to try to differentiate; and then the poor performance of our currently used culture-based technologies,” he said. <Read More> 

WHO Launches First-Ever Guidelines on Meningitis Diagnosis, Treatment and Care – April 10, 2025 – The World Health Organization (WHO) has published its first-ever global guidelines for meningitis diagnosis, treatment and care, aiming to speed up detection, ensure timely treatment, and improve long-term care for those affected. By bringing together the latest evidence-based recommendations, the guidelines provide a critical tool for reducing deaths and disability caused by the disease. Despite effective treatments and vaccines against some forms of meningitis, the disease remains a significant global health threat. <Read More>

340B in the News

Cassidy Calls for 340B Reform, Increased Oversight of Hospitals, Contract Pharmacies – April 24, 2025 – A new report on the 340B Drug Pricing Program released Thursday by the chairman of the Senate Health, Education, Labor and Pensions Committee calls for “much-needed” legislative reforms around transparency and oversight of the contentious discount program. Chairman Bill Cassidy, M.D., R-Louisiana, kicked off his investigation in late 2023 as a response to substantial increases in the program’s utilization among providers. Over 60,000 total covered entities were participating as of February 2025, per the report, with federal and proprietary data from 2023 suggesting that the roughly $66.3 billion in discounted outpatient drugs purchased through the program would have hit $124.1 billion wholesale. <Read More> 

Read More

Clinical Insights: May 1st, 2025

New Drug/Vaccine Approval

Penpulimab-kcqx Injection – New Drug Approval – April 23, 2025 – The Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Efficacy of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 (NCT04974398), a randomized, double-blind, multi-center trial in 291 patients with recurrent or metastatic NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease. <Read More>

Vanrafia® (atrasentan) Tablets – New Drug Approval – April 2, 2025 – Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. Vanrafia® is a once-daily, non-steroidal, oral treatment that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. <Read More> 

New Indication / Dosage / Formulation Approval

Camzyos® (mavacamten) Capsules – New Label Expansion – April 17, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has updated the U.S. Prescribing Information for Camzyos® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules), simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications. Camzyos® is the first and only FDA-approved cardiac myosin inhibitor for the treatment of adults with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. <Read More> 

Dupixent® (dupilumab) Injection – New Label Expansion – April 17, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. <Read More> 

Valtoco® (diazepam) Nasal Spray – New Label Expansion – April 16, 2025 – Neurelis, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco® (diazepam nasal spray) for short-term treatment of seizure clusters (also known as “acute repetitive seizures”) that are different from a person’s normal seizure pattern in people 2 years of age and older. Valtoco® is a proprietary formulation which utilizes an absorption enhancement technology, Intravail®, to enable the noninvasive, enhanced intranasal delivery of diazepam.  The intranasal formulation of Neurelis’ Valtoco® was previously recognized by the FDA as clinically superior to the rectal gel formulation of diazepam resulting in its orphan drug exclusivity designation. <Read More>

Isturisa® (osilodrostat) Tablets – New Label Expansion – April 15, 2025 – Recordati announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa® (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This is an expansion of the previous indication for the treatment of patients with Cushing’s disease, which is a sub-type of Cushing’s syndrome. <Read More> 

Livmarli® (maralixibat) Oral Solution and Tablets – New Label Expansion – April 14, 2025 – Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Livmarli® (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). <Read More>

Opdivo® (nivolumab) Injection – New Label Expansion – April 11, 2025 – The Food and Drug Administration approved nivolumab (Opdivo®, Bristol Myers Squibb Company) with ipilimumab (Yervoy®, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Efficacy was evaluated in CHECKMATE-9DW (NCT04039607), a randomized (1:1), open-label trial in 668 adults with unresectable or metastatic HCC. Patients had histologically confirmed HCC, Child Pugh Class A, ECOG performance status 0 or 1, and no prior systemic therapy for advanced disease. <Read More> 

Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection – New Label Expansion – April 10, 2025 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject Vyvgart® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). <Read More> 

Vitrakvi® (larotrectinib) Capsules and Oral Solution – New Label Expansion – April 9, 2025 – Bayer announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Vitrakvi® (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Vitrakvi® has demonstrated clinically meaningful and durable responses across a range of NTRK fusion-positive solid tumors. Vitrakvi® was first granted accelerated approval by FDA in November 2018. <Read More> 

Opdivo® (nivolumab) Injection – New Label Expansion – April 8, 2025 – the Food and Drug Administration approved nivolumab (Opdivo®, Bristol Myers Squibb Company) with ipilimumab (Yervoy®, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan. <Read More> 

Yuflyma® (adalimumab-aaty) Injection – New Label Expansion – April 7, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated Yuflyma® (adalimumab-aaty), as an interchangeable biosimilar to Humira® (adalimumab). Yuflyma® is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications. <Read More>  

Uplizna® (inebilizumab-cdon) Injection – New Label Expansion – April 3, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine's potential to benefit patients. <Read More>  

Tryvio™ (aprocitentan) Tablets – New Label Expansion – April 2, 2025 – Idorsia Ltd (SIX: IDIA) announced that – effective immediately – the US FDA has fully released Tryvio™ (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement. Tryvio™ is Idorsia’s dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. The US FDA has determined that a REMS is no longer necessary to ensure the benefits of Tryvio™ outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information. The FDA have therefore removed the requirement to minimize the burden on the healthcare delivery system of complying with the REMS. <Read More> 

Jynneos® (smallpox and mpox vaccine) Injection – New Label Expansion – March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of Jynneos® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. <Read More>

New Drug Shortage

April 28, 2025

April 25, 2025

April 24, 2025

April 23, 2025

April 22, 2025

Updated Drug Shortage

April 24, 2025

April 23, 2025

April 22, 2025

April 21, 2025

April 18, 2025

New Drug Recall and Safety Alerts

Ropivacaine Hydrochloride Injection, USP 500mg/100mL by Amneal Pharmaceutical LLC - New Voluntary Recall – April 18, 2025 - Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag. <Read More>

New Generic/Biosimilar Approval and Launch

Jobevne™ (bevacizumab-nwgd) Injection – New Avastin® Biosimilar Approval – April 9, 2025 – Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. Jobevne™, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). Jobevne™ is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. <Read More> 

Clinical and Pharmacy News

Eli Lilly Sues Companies Selling Alternative Versions of its Weight Loss Drug – April 23, 2025 – Eli Lilly, the drugmaker behind the blockbuster weight loss drug Zepboundâ, is suing four telehealth companies for allegedly selling illegal copies of the drug made by compounding pharmacies. Compounded drugs aren't generics. Rather, they are essentially copies that are allowed to be made by special pharmacies called compounding pharmacies during drug shortages. Tirzepatide, the active ingredient in Lilly's Zepboundâ and Mounjaroâ for Type 2 diabetes, was in shortage for two years until Dec. 19, 2024. The U.S. Food and Drug Administration required an end to making the copies by mid-March, but pharmacies could sell stock already produced until it ran out or expired. And compounders can generally make custom drugs for patients with a doctor's prescription as they do for patients with allergies to certain preservatives in medications, for example. <Read More> 

Rethinking Psoriasis Severity for Better Treatment Access – April 21, 2025 – Psoriasis (PsO) is a chronic inflammatory skin condition that affects nearly 8 million adults in the U.S. and significantly impacts both physical and mental health. Early and aggressive treatment can greatly improve symptom relief, but many people with moderate to severe psoriasis do not receive this due to rigid treatment criteria. A new study is challenging the way doctors determine who qualifies for systemic treatment—and it could lead to better care for patients whose disease goes underestimated. <Read More> 

Machine Learning Improves Fluid Overload Prediction in ICU – April 17, 2025 – A machine learning (ML)-identified medication cluster more accurately predicts fluid overload (FO) in ICU patients than traditional models, according to a new study from the MRC-ICU Investigator Team, a multicenter group of researchers focused on data-driven, optimal pharmacotherapeutic care for critical care patients (Pharmacotherapy 2025;45[2]:76-86). This result also suggests that artificial intelligence could be used to identify other medication-related predictive risk factors in critical care that may be less straightforward than FO, the investigators noted. <Read More> 

State Bans PBMs From Owning Pharmacies – April 17, 2025 – Arkansas Gov. Sarah Huckabee Sanders (R) signed legislation Wednesday prohibiting pharmacy benefit managers from owning or operating pharmacies, becoming the first state to enact such a restriction. The measure comes as other states are considering restrictions on pharmacy benefit managers, which run prescription drug coverage for big clients that include health insurers and employers that provide coverage. Supporters of the restrictions have said pharmacy benefit managers are forcing independent pharmacies, especially in rural areas, out of business. <Read More>

Leaked HHS Budget Reveals 30% Cuts, Elimination of Many Core Services – April 17, 2025 – A 64-page leaked budget proposal from the U.S. Department of Health and Human Services (HHS) reveals more than $40 billion in cuts to various programs, including the total elimination of some and the consolidation of others. The unfinalized plan, first reported by the Washington Post, shows that the proposed cuts extend beyond the termination of diversity, equity and inclusion (DEI) initiatives. Services related to teen pregnancy prevention, lead safety, rural development, energy assistance, and Head Start have all been completely zeroed out in the proposed budget, along with research initiatives focused on Lyme disease, autism, and firearm-related deaths. <Read More> 

Trump Order Seeks Changes to Medicare Drug Price Negotiation Program, PBM Reform – April 16, 2025 – President Donald Trump has signed an executive order looking to modify the Inflation Reduction Act’s (IRA's) drug price negotiation program, among other policy shifts. The wide-ranging order requires the Department of Health and Human Services to seek public comment on the drug price negotiation program, which effectively requires manufacturers to agree to lower prices for certain drugs, for potential changes in upcoming years. “The guidance shall improve the transparency of the Medicare drug price negotiation program, prioritize the selection of prescription drugs with high costs to the Medicare program and minimize any negative impacts of the maximum fair price on pharmaceutical innovation within the United States,” the order reads. <Read More> 

IL-6 Promising Biomarker for Diagnosing Sepsis Early – April 16, 2025 – Because it rises early after an infectious insult, interleukin-6 (IL-6) may be an effective biomarker for predicting sepsis in high-risk patients, including neonates, children and pregnant women, said Seán O. Whelan, MB, BAO, BCh, BSc, MSc, MRCPI, at ESCMID Global 2025, in Vienna (abstract O0177). Managing sepsis is a race against time, so the clinical diagnosis of sepsis is always a challenge, but especially in these three groups, because physiologic changes can obscure its early signs, explained Dr. Whelan, a clinical microbiology trainee in Dublin. Specific challenges include “difficulties with consensus definitions for what sepsis means in each of these populations; the presence of confounding co-pathologies that closely mimic sepsis and may be far more common than sepsis, which are difficult to try to differentiate; and then the poor performance of our currently used culture-based technologies,” he said. <Read More> 

WHO Launches First-Ever Guidelines on Meningitis Diagnosis, Treatment and Care – April 10, 2025 – The World Health Organization (WHO) has published its first-ever global guidelines for meningitis diagnosis, treatment and care, aiming to speed up detection, ensure timely treatment, and improve long-term care for those affected. By bringing together the latest evidence-based recommendations, the guidelines provide a critical tool for reducing deaths and disability caused by the disease. Despite effective treatments and vaccines against some forms of meningitis, the disease remains a significant global health threat. <Read More>

340B in the News

Cassidy Calls for 340B Reform, Increased Oversight of Hospitals, Contract Pharmacies – April 24, 2025 – A new report on the 340B Drug Pricing Program released Thursday by the chairman of the Senate Health, Education, Labor and Pensions Committee calls for “much-needed” legislative reforms around transparency and oversight of the contentious discount program. Chairman Bill Cassidy, M.D., R-Louisiana, kicked off his investigation in late 2023 as a response to substantial increases in the program’s utilization among providers. Over 60,000 total covered entities were participating as of February 2025, per the report, with federal and proprietary data from 2023 suggesting that the roughly $66.3 billion in discounted outpatient drugs purchased through the program would have hit $124.1 billion wholesale. <Read More> 

Read More

Clinical Insights: May 1st, 2025

New Drug/Vaccine Approval

Penpulimab-kcqx Injection – New Drug Approval – April 23, 2025 – The Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Efficacy of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 (NCT04974398), a randomized, double-blind, multi-center trial in 291 patients with recurrent or metastatic NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease. <Read More>

Vanrafia® (atrasentan) Tablets – New Drug Approval – April 2, 2025 – Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. Vanrafia® is a once-daily, non-steroidal, oral treatment that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. <Read More> 

New Indication / Dosage / Formulation Approval

Camzyos® (mavacamten) Capsules – New Label Expansion – April 17, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has updated the U.S. Prescribing Information for Camzyos® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules), simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications. Camzyos® is the first and only FDA-approved cardiac myosin inhibitor for the treatment of adults with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. <Read More> 

Dupixent® (dupilumab) Injection – New Label Expansion – April 17, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. <Read More> 

Valtoco® (diazepam) Nasal Spray – New Label Expansion – April 16, 2025 – Neurelis, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco® (diazepam nasal spray) for short-term treatment of seizure clusters (also known as “acute repetitive seizures”) that are different from a person’s normal seizure pattern in people 2 years of age and older. Valtoco® is a proprietary formulation which utilizes an absorption enhancement technology, Intravail®, to enable the noninvasive, enhanced intranasal delivery of diazepam.  The intranasal formulation of Neurelis’ Valtoco® was previously recognized by the FDA as clinically superior to the rectal gel formulation of diazepam resulting in its orphan drug exclusivity designation. <Read More>

Isturisa® (osilodrostat) Tablets – New Label Expansion – April 15, 2025 – Recordati announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa® (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This is an expansion of the previous indication for the treatment of patients with Cushing’s disease, which is a sub-type of Cushing’s syndrome. <Read More> 

Livmarli® (maralixibat) Oral Solution and Tablets – New Label Expansion – April 14, 2025 – Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Livmarli® (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). <Read More>

Opdivo® (nivolumab) Injection – New Label Expansion – April 11, 2025 – The Food and Drug Administration approved nivolumab (Opdivo®, Bristol Myers Squibb Company) with ipilimumab (Yervoy®, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Efficacy was evaluated in CHECKMATE-9DW (NCT04039607), a randomized (1:1), open-label trial in 668 adults with unresectable or metastatic HCC. Patients had histologically confirmed HCC, Child Pugh Class A, ECOG performance status 0 or 1, and no prior systemic therapy for advanced disease. <Read More> 

Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection – New Label Expansion – April 10, 2025 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject Vyvgart® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). <Read More> 

Vitrakvi® (larotrectinib) Capsules and Oral Solution – New Label Expansion – April 9, 2025 – Bayer announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Vitrakvi® (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Vitrakvi® has demonstrated clinically meaningful and durable responses across a range of NTRK fusion-positive solid tumors. Vitrakvi® was first granted accelerated approval by FDA in November 2018. <Read More> 

Opdivo® (nivolumab) Injection – New Label Expansion – April 8, 2025 – the Food and Drug Administration approved nivolumab (Opdivo®, Bristol Myers Squibb Company) with ipilimumab (Yervoy®, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan. <Read More> 

Yuflyma® (adalimumab-aaty) Injection – New Label Expansion – April 7, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated Yuflyma® (adalimumab-aaty), as an interchangeable biosimilar to Humira® (adalimumab). Yuflyma® is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications. <Read More>  

Uplizna® (inebilizumab-cdon) Injection – New Label Expansion – April 3, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine's potential to benefit patients. <Read More>  

Tryvio™ (aprocitentan) Tablets – New Label Expansion – April 2, 2025 – Idorsia Ltd (SIX: IDIA) announced that – effective immediately – the US FDA has fully released Tryvio™ (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement. Tryvio™ is Idorsia’s dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. The US FDA has determined that a REMS is no longer necessary to ensure the benefits of Tryvio™ outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information. The FDA have therefore removed the requirement to minimize the burden on the healthcare delivery system of complying with the REMS. <Read More> 

Jynneos® (smallpox and mpox vaccine) Injection – New Label Expansion – March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of Jynneos® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. <Read More>

New Drug Shortage

April 28, 2025

April 25, 2025

April 24, 2025

April 23, 2025

April 22, 2025

Updated Drug Shortage

April 24, 2025

April 23, 2025

April 22, 2025

April 21, 2025

April 18, 2025

New Drug Recall and Safety Alerts

Ropivacaine Hydrochloride Injection, USP 500mg/100mL by Amneal Pharmaceutical LLC - New Voluntary Recall – April 18, 2025 - Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag. <Read More>

New Generic/Biosimilar Approval and Launch

Jobevne™ (bevacizumab-nwgd) Injection – New Avastin® Biosimilar Approval – April 9, 2025 – Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. Jobevne™, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). Jobevne™ is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. <Read More> 

Clinical and Pharmacy News

Eli Lilly Sues Companies Selling Alternative Versions of its Weight Loss Drug – April 23, 2025 – Eli Lilly, the drugmaker behind the blockbuster weight loss drug Zepboundâ, is suing four telehealth companies for allegedly selling illegal copies of the drug made by compounding pharmacies. Compounded drugs aren't generics. Rather, they are essentially copies that are allowed to be made by special pharmacies called compounding pharmacies during drug shortages. Tirzepatide, the active ingredient in Lilly's Zepboundâ and Mounjaroâ for Type 2 diabetes, was in shortage for two years until Dec. 19, 2024. The U.S. Food and Drug Administration required an end to making the copies by mid-March, but pharmacies could sell stock already produced until it ran out or expired. And compounders can generally make custom drugs for patients with a doctor's prescription as they do for patients with allergies to certain preservatives in medications, for example. <Read More> 

Rethinking Psoriasis Severity for Better Treatment Access – April 21, 2025 – Psoriasis (PsO) is a chronic inflammatory skin condition that affects nearly 8 million adults in the U.S. and significantly impacts both physical and mental health. Early and aggressive treatment can greatly improve symptom relief, but many people with moderate to severe psoriasis do not receive this due to rigid treatment criteria. A new study is challenging the way doctors determine who qualifies for systemic treatment—and it could lead to better care for patients whose disease goes underestimated. <Read More> 

Machine Learning Improves Fluid Overload Prediction in ICU – April 17, 2025 – A machine learning (ML)-identified medication cluster more accurately predicts fluid overload (FO) in ICU patients than traditional models, according to a new study from the MRC-ICU Investigator Team, a multicenter group of researchers focused on data-driven, optimal pharmacotherapeutic care for critical care patients (Pharmacotherapy 2025;45[2]:76-86). This result also suggests that artificial intelligence could be used to identify other medication-related predictive risk factors in critical care that may be less straightforward than FO, the investigators noted. <Read More> 

State Bans PBMs From Owning Pharmacies – April 17, 2025 – Arkansas Gov. Sarah Huckabee Sanders (R) signed legislation Wednesday prohibiting pharmacy benefit managers from owning or operating pharmacies, becoming the first state to enact such a restriction. The measure comes as other states are considering restrictions on pharmacy benefit managers, which run prescription drug coverage for big clients that include health insurers and employers that provide coverage. Supporters of the restrictions have said pharmacy benefit managers are forcing independent pharmacies, especially in rural areas, out of business. <Read More>

Leaked HHS Budget Reveals 30% Cuts, Elimination of Many Core Services – April 17, 2025 – A 64-page leaked budget proposal from the U.S. Department of Health and Human Services (HHS) reveals more than $40 billion in cuts to various programs, including the total elimination of some and the consolidation of others. The unfinalized plan, first reported by the Washington Post, shows that the proposed cuts extend beyond the termination of diversity, equity and inclusion (DEI) initiatives. Services related to teen pregnancy prevention, lead safety, rural development, energy assistance, and Head Start have all been completely zeroed out in the proposed budget, along with research initiatives focused on Lyme disease, autism, and firearm-related deaths. <Read More> 

Trump Order Seeks Changes to Medicare Drug Price Negotiation Program, PBM Reform – April 16, 2025 – President Donald Trump has signed an executive order looking to modify the Inflation Reduction Act’s (IRA's) drug price negotiation program, among other policy shifts. The wide-ranging order requires the Department of Health and Human Services to seek public comment on the drug price negotiation program, which effectively requires manufacturers to agree to lower prices for certain drugs, for potential changes in upcoming years. “The guidance shall improve the transparency of the Medicare drug price negotiation program, prioritize the selection of prescription drugs with high costs to the Medicare program and minimize any negative impacts of the maximum fair price on pharmaceutical innovation within the United States,” the order reads. <Read More> 

IL-6 Promising Biomarker for Diagnosing Sepsis Early – April 16, 2025 – Because it rises early after an infectious insult, interleukin-6 (IL-6) may be an effective biomarker for predicting sepsis in high-risk patients, including neonates, children and pregnant women, said Seán O. Whelan, MB, BAO, BCh, BSc, MSc, MRCPI, at ESCMID Global 2025, in Vienna (abstract O0177). Managing sepsis is a race against time, so the clinical diagnosis of sepsis is always a challenge, but especially in these three groups, because physiologic changes can obscure its early signs, explained Dr. Whelan, a clinical microbiology trainee in Dublin. Specific challenges include “difficulties with consensus definitions for what sepsis means in each of these populations; the presence of confounding co-pathologies that closely mimic sepsis and may be far more common than sepsis, which are difficult to try to differentiate; and then the poor performance of our currently used culture-based technologies,” he said. <Read More> 

WHO Launches First-Ever Guidelines on Meningitis Diagnosis, Treatment and Care – April 10, 2025 – The World Health Organization (WHO) has published its first-ever global guidelines for meningitis diagnosis, treatment and care, aiming to speed up detection, ensure timely treatment, and improve long-term care for those affected. By bringing together the latest evidence-based recommendations, the guidelines provide a critical tool for reducing deaths and disability caused by the disease. Despite effective treatments and vaccines against some forms of meningitis, the disease remains a significant global health threat. <Read More>

340B in the News

Cassidy Calls for 340B Reform, Increased Oversight of Hospitals, Contract Pharmacies – April 24, 2025 – A new report on the 340B Drug Pricing Program released Thursday by the chairman of the Senate Health, Education, Labor and Pensions Committee calls for “much-needed” legislative reforms around transparency and oversight of the contentious discount program. Chairman Bill Cassidy, M.D., R-Louisiana, kicked off his investigation in late 2023 as a response to substantial increases in the program’s utilization among providers. Over 60,000 total covered entities were participating as of February 2025, per the report, with federal and proprietary data from 2023 suggesting that the roughly $66.3 billion in discounted outpatient drugs purchased through the program would have hit $124.1 billion wholesale. <Read More> 

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Clinical Insights: April 2nd, 2025

New Drug/Vaccine Approval

Qfitlia™ (fitusiran) Injection – New Drug Approval – March 28, 2025 – The US Food and Drug Administration (FDA) has approved Qfitlia™ (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates (ABR) across hemophilia patients with or without inhibitors. <Read More>

Vykat™ XR FDA Approval History – New Drug Approval – March 26, 2025 – Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Vykat XR™ (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). Soleno expects Vykat XR™ to be available in the U.S. beginning in April 2025. <Read More> 

Blujepa™ (gepotidacin) Tablets – New Drug Approval – March 25, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Blujepa™ (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. Discovered by GSK scientists, Blujepa™ is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. <Read More> 

Gozellix® (gallium Ga 68 gozetotide) Injection Kit – New Drug Approval – March 20, 2025 – Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging agent for prostate cancer. <Read More> 

Arbli™ (losartan potassium) Oral Suspension – New Drug Approval – March 13, 2025 – Scienture Holdings, Inc. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli™ (losartan potassium) Oral Suspension, 10 mg/mL. <Read More>

Encelto™ (revakinagene taroretcel-lwey) Intravitreal Implant - formerly NT-501 – New Drug Approval – March 5, 2025 – Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced that the U.S. Food and Drug Administration (FDA), has approved Encelto™ (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel). <Read More> 

New Indication / Dosage / Formulation Approval

Pluvicto® (lutetium lu 177 vipivotide tetraxetan) Injection – New Label Expansion – March 28, 2025 – Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – March 28, 2025 - AstraZeneca’s Imfinzi® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi® as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). <Read More> 

Cabometyx® (cabozantinib) Tablets – New Label Expansion – March 26, 2025 - Exelixis, Inc. (Nasdaq: EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved Cabometyx® (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET). <Read More> 

Egrifta WR™ (tesamorelin) Injection – New Label Expansion – March 25, 2025 - Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename Egrifta WR™. <Read More>

Amvuttra® (vutrisiran) Injection – New Label Expansion – March 20, 2025 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, Amvuttra® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. <Read More> 

Fabhalta® (iptacopan) Capsules – New Label Expansion – March 20, 2025 - Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition. <Read More>

Tremfya® (guselkumab) Injection – New Label Expansion – March 20, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – March 19, 2025 -  The Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda®, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). <Read More> 

Iluvien® (fluocinolone acetonide) Intravitreal Implant – New Label Expansion – March 12, 2025 - ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Iluvien® (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – March 6, 2025 - scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Furoscix® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). <Read More>

neffy® (epinephrine) Nasal Spray – New Label Expansion – March 5, 2025 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years. <Read More> 

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – March 4, 2025 – BeiGene, Ltd. (NASDAQ: ONC; 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-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). <Read More> 

New Drug Shortage

March 28, 2025

March 24, 2025

March 18, 2025

March 17, 2025

March 5, 2025

March 4, 2025

Updated Drug Shortage

March 30, 2025

March 28, 2025

March 27, 2025

March 24, 2025

March 21, 2025

New Drug Recall and Safety Alerts

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Dr. Reddy’s - New Voluntary Recall – March 13, 2025 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States. The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. <Read More>

New Generic/Biosimilar Approval and Launch

Stoboclo® (denosumab-bmwo) Injection - formerly CT-P41 – New Proliaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More> 

Osenvelt® (denosumab-bmwo) Injection - formerly CT-P41 – New Xvegaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More>

Conexxence® (denosumab-bnht) Injection – New Prolia® Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More> 

Bomyntra® (denosumab-bnht) Injection – New Xvegaâ Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More>

Clinical and Pharmacy News

The Key to Solving Medication Errors is at the Intersection of Technology and Standards  – April 1, 2025 – By integrating industry standards into e-prescribing software, prescribing organizations can reduce errors to improve patient outcomes and lessen the burden of medication-related errors on healthcare systems. Here’s a look at the new National Council for Prescription Drug Programs (NCPDP) Sig Standard aimed at improving prescription accuracy. 1.5 million people are affected by medication errors each year, posing a significant risk to patients’ safety and increasing healthcare costs. While providers do everything in their power to prevent medication errors, interoperability and lack of visibility into a patient’s medication history can cause serious challenges. <Read More> 

Medical Gaslighting Tops List of Highest Patient Safety Risks – March 28, 2025 – The risks associated with medical professionals dismissing patient, family and caregiver concerns — also called “medical gaslighting” — ranked highest on an annual list of patient safety concerns compiled by the nonprofit organization ECRI. Insufficient governance of AI in health care, the viral spread of medical misinformation, and medical errors and delays in care resulting from cybersecurity breaches also were listed as significant concerns. <Read More>

AI Can Help Doctors Give Intravenous Nutrition to Preemies, Stanford Medicine Study Finds  – March 25, 2025 – An algorithm that learned from tens of thousands of nutrition prescriptions for premature babies could reduce medical errors and better identify what nutrients the smallest patients need. Artificial intelligence can improve intravenous nutrition for premature babies, a Stanford Medicine study has shown. The study, which published March 25 in Nature Medicine, is among the first to demonstrate how an AI algorithm can enable doctors to make better clinical decisions for sick newborns. <Read More> 

Pharmacy Benefit Managers Lining Pockets at Expense of Patients, Say Lawmakers – March 25, 2025 – Third-party companies known as pharmacy benefit managers, which administer prescription drug benefits for health insurance plans, employers, and other organizations including governments, are driving up prescription drug costs, putting small pharmacies out of business, and interfering in the relationship between doctors and their patients, says Sen. Rochelle Nguyen, a Democrat from Las Vegas and the sponsor of Senate Bill 316, a measure that seeks to reform PBMs.  Nevadans are being deprived of “life-changing and life-saving prescription drugs and often have to make difficult decisions based on what they can and cannot afford,” Nguyen told members of the Senate Committee on Labor and Commerce during a hearing Monday, adding escalating prescription prices are just one component of high costs. “This isn’t a magic pill that’s going to solve all our health care problems.” <Read More> 

Spending Growth on GLP-1s Outpaces Specialty Drugs: Evernorth Study – March 25, 2025 – Spending on GLP-1 drugs continues to rise, after outpacing trends among specialty drugs for the first time in 2023, according to a new report from Evernorth. Pharmaceutical spending overall has grown significantly in recent years, but it has accelerated since semaglutide earned approval for chronic weight management in 2021. Afterward, the rate of annual growth rose from 2.1% in 2021 to 12.8% in 2024, according to the report. Specialty pharmacy has traditionally been the key source of growth in pharmacy spend. For comparison, in 2019, spending for traditional medications decreased by 5% while spending on specialty drugs grew by 11.5%. <Read More> 

How Health Systems Can Thrive in Navigating the Specialty Pharmacy Landscape  – March 24, 2025 – Specialty pharmacies must meet complex requirements, introducing administrative requirements that can be challenging for health systems to manage internally. Here some strategies that can be employed. The demand for specialty medications is on the rise in the United States as people living with complex health conditions increasingly rely on new treatments and therapies to manage their health. By partnering with an advisory service, health systems can take advantage of established expertise to evaluate and choose from among the breadth and complexity of potential solutions for operating and optimizing an integrated specialty pharmacy. <Read More>

DEA Warns of Electronic Prescription Fraud – March 21, 2025 – The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video. “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.” <Read More> 

Ensitrelvir Reduced the Risk for COVID-19 by 67% – March 14, 2025 – Ensitrelvir, an antiviral being developed to prevent COVID-19, reduced the risk of developing the infection by 67% in uninfected people after exposure to SARS-CoV-2 compared with placebo at day 10, according to results presented at CROI 2025, held in San Francisco (abstract 200). The SCORPIO-PEP (Stopping COVID-19 pRogression with early Protease InhibitOr treatment–Post-Exposure Prophylaxis) trial assessed 2,387 study participants, who were 12 years of age and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment. The participants were exposed to a person living in the household who developed symptomatic COVID-19. In this double-blind trial, study participants were randomly assigned to receive 125 mg of ensitrelvir or placebo, once daily, and began prophylaxis within 72 hours of symptom onset in the household member with COVID-19, according to Frederick Hayden, MD, a professor emeritus at the University of Virginia School of Medicine, in Charlottesville. <Read More> 

340B in the News

The Case for 340B Done Right – March 30, 2025 – The federal 340B Drug Pricing Program, which requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to healthcare organizations that care for many uninsured and low-income patients, is facing intense scrutiny and calls for reform. The program’s intent has always been to stretch limited federal resources to reduce the price of outpatient pharmaceuticals and expand health services to our most vulnerable communities. In too many cases, that’s just not what’s happening, and in recent weeks, the media has been shining a spotlight on some of the most cynical deployment of these funds towards profits over patients. <Read More>

HHS Files Brief in 340B Rebate Model Case – March 17, 2025 – The Department of Health and Human Services said its decision to prevent drug companies from implementing a 340B rebate model “was within its statutory authority,” according to a department brief filed March 17 with the U.S. District Court for the District of Columbia. In addition, the brief said the drug companies’ “proposed cash rebate models would have upended the way the 340B Program has operated for more than thirty years” and the agency’s decision to prevent the models from being implemented was “not arbitrary and capricious.” The HHS brief is in cases brought by Eli Lilly, Bristol Meyers Squibb and Novartis. <Read More> 

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Clinical Insights: April 2nd, 2025

New Drug/Vaccine Approval

Qfitlia™ (fitusiran) Injection – New Drug Approval – March 28, 2025 – The US Food and Drug Administration (FDA) has approved Qfitlia™ (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates (ABR) across hemophilia patients with or without inhibitors. <Read More>

Vykat™ XR FDA Approval History – New Drug Approval – March 26, 2025 – Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Vykat XR™ (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). Soleno expects Vykat XR™ to be available in the U.S. beginning in April 2025. <Read More> 

Blujepa™ (gepotidacin) Tablets – New Drug Approval – March 25, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Blujepa™ (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. Discovered by GSK scientists, Blujepa™ is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. <Read More> 

Gozellix® (gallium Ga 68 gozetotide) Injection Kit – New Drug Approval – March 20, 2025 – Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging agent for prostate cancer. <Read More> 

Arbli™ (losartan potassium) Oral Suspension – New Drug Approval – March 13, 2025 – Scienture Holdings, Inc. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli™ (losartan potassium) Oral Suspension, 10 mg/mL. <Read More>

Encelto™ (revakinagene taroretcel-lwey) Intravitreal Implant - formerly NT-501 – New Drug Approval – March 5, 2025 – Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced that the U.S. Food and Drug Administration (FDA), has approved Encelto™ (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel). <Read More> 

New Indication / Dosage / Formulation Approval

Pluvicto® (lutetium lu 177 vipivotide tetraxetan) Injection – New Label Expansion – March 28, 2025 – Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – March 28, 2025 - AstraZeneca’s Imfinzi® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi® as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). <Read More> 

Cabometyx® (cabozantinib) Tablets – New Label Expansion – March 26, 2025 - Exelixis, Inc. (Nasdaq: EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved Cabometyx® (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET). <Read More> 

Egrifta WR™ (tesamorelin) Injection – New Label Expansion – March 25, 2025 - Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename Egrifta WR™. <Read More>

Amvuttra® (vutrisiran) Injection – New Label Expansion – March 20, 2025 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, Amvuttra® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. <Read More> 

Fabhalta® (iptacopan) Capsules – New Label Expansion – March 20, 2025 - Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition. <Read More>

Tremfya® (guselkumab) Injection – New Label Expansion – March 20, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – March 19, 2025 -  The Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda®, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). <Read More> 

Iluvien® (fluocinolone acetonide) Intravitreal Implant – New Label Expansion – March 12, 2025 - ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Iluvien® (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – March 6, 2025 - scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Furoscix® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). <Read More>

neffy® (epinephrine) Nasal Spray – New Label Expansion – March 5, 2025 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years. <Read More> 

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – March 4, 2025 – BeiGene, Ltd. (NASDAQ: ONC; 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-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). <Read More> 

New Drug Shortage

March 28, 2025

March 24, 2025

March 18, 2025

March 17, 2025

March 5, 2025

March 4, 2025

Updated Drug Shortage

March 30, 2025

March 28, 2025

March 27, 2025

March 24, 2025

March 21, 2025

New Drug Recall and Safety Alerts

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Dr. Reddy’s - New Voluntary Recall – March 13, 2025 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States. The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. <Read More>

New Generic/Biosimilar Approval and Launch

Stoboclo® (denosumab-bmwo) Injection - formerly CT-P41 – New Proliaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More> 

Osenvelt® (denosumab-bmwo) Injection - formerly CT-P41 – New Xvegaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More>

Conexxence® (denosumab-bnht) Injection – New Prolia® Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More> 

Bomyntra® (denosumab-bnht) Injection – New Xvegaâ Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More>

Clinical and Pharmacy News

The Key to Solving Medication Errors is at the Intersection of Technology and Standards  – April 1, 2025 – By integrating industry standards into e-prescribing software, prescribing organizations can reduce errors to improve patient outcomes and lessen the burden of medication-related errors on healthcare systems. Here’s a look at the new National Council for Prescription Drug Programs (NCPDP) Sig Standard aimed at improving prescription accuracy. 1.5 million people are affected by medication errors each year, posing a significant risk to patients’ safety and increasing healthcare costs. While providers do everything in their power to prevent medication errors, interoperability and lack of visibility into a patient’s medication history can cause serious challenges. <Read More> 

Medical Gaslighting Tops List of Highest Patient Safety Risks – March 28, 2025 – The risks associated with medical professionals dismissing patient, family and caregiver concerns — also called “medical gaslighting” — ranked highest on an annual list of patient safety concerns compiled by the nonprofit organization ECRI. Insufficient governance of AI in health care, the viral spread of medical misinformation, and medical errors and delays in care resulting from cybersecurity breaches also were listed as significant concerns. <Read More>

AI Can Help Doctors Give Intravenous Nutrition to Preemies, Stanford Medicine Study Finds  – March 25, 2025 – An algorithm that learned from tens of thousands of nutrition prescriptions for premature babies could reduce medical errors and better identify what nutrients the smallest patients need. Artificial intelligence can improve intravenous nutrition for premature babies, a Stanford Medicine study has shown. The study, which published March 25 in Nature Medicine, is among the first to demonstrate how an AI algorithm can enable doctors to make better clinical decisions for sick newborns. <Read More> 

Pharmacy Benefit Managers Lining Pockets at Expense of Patients, Say Lawmakers – March 25, 2025 – Third-party companies known as pharmacy benefit managers, which administer prescription drug benefits for health insurance plans, employers, and other organizations including governments, are driving up prescription drug costs, putting small pharmacies out of business, and interfering in the relationship between doctors and their patients, says Sen. Rochelle Nguyen, a Democrat from Las Vegas and the sponsor of Senate Bill 316, a measure that seeks to reform PBMs.  Nevadans are being deprived of “life-changing and life-saving prescription drugs and often have to make difficult decisions based on what they can and cannot afford,” Nguyen told members of the Senate Committee on Labor and Commerce during a hearing Monday, adding escalating prescription prices are just one component of high costs. “This isn’t a magic pill that’s going to solve all our health care problems.” <Read More> 

Spending Growth on GLP-1s Outpaces Specialty Drugs: Evernorth Study – March 25, 2025 – Spending on GLP-1 drugs continues to rise, after outpacing trends among specialty drugs for the first time in 2023, according to a new report from Evernorth. Pharmaceutical spending overall has grown significantly in recent years, but it has accelerated since semaglutide earned approval for chronic weight management in 2021. Afterward, the rate of annual growth rose from 2.1% in 2021 to 12.8% in 2024, according to the report. Specialty pharmacy has traditionally been the key source of growth in pharmacy spend. For comparison, in 2019, spending for traditional medications decreased by 5% while spending on specialty drugs grew by 11.5%. <Read More> 

How Health Systems Can Thrive in Navigating the Specialty Pharmacy Landscape  – March 24, 2025 – Specialty pharmacies must meet complex requirements, introducing administrative requirements that can be challenging for health systems to manage internally. Here some strategies that can be employed. The demand for specialty medications is on the rise in the United States as people living with complex health conditions increasingly rely on new treatments and therapies to manage their health. By partnering with an advisory service, health systems can take advantage of established expertise to evaluate and choose from among the breadth and complexity of potential solutions for operating and optimizing an integrated specialty pharmacy. <Read More>

DEA Warns of Electronic Prescription Fraud – March 21, 2025 – The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video. “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.” <Read More> 

Ensitrelvir Reduced the Risk for COVID-19 by 67% – March 14, 2025 – Ensitrelvir, an antiviral being developed to prevent COVID-19, reduced the risk of developing the infection by 67% in uninfected people after exposure to SARS-CoV-2 compared with placebo at day 10, according to results presented at CROI 2025, held in San Francisco (abstract 200). The SCORPIO-PEP (Stopping COVID-19 pRogression with early Protease InhibitOr treatment–Post-Exposure Prophylaxis) trial assessed 2,387 study participants, who were 12 years of age and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment. The participants were exposed to a person living in the household who developed symptomatic COVID-19. In this double-blind trial, study participants were randomly assigned to receive 125 mg of ensitrelvir or placebo, once daily, and began prophylaxis within 72 hours of symptom onset in the household member with COVID-19, according to Frederick Hayden, MD, a professor emeritus at the University of Virginia School of Medicine, in Charlottesville. <Read More> 

340B in the News

The Case for 340B Done Right – March 30, 2025 – The federal 340B Drug Pricing Program, which requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to healthcare organizations that care for many uninsured and low-income patients, is facing intense scrutiny and calls for reform. The program’s intent has always been to stretch limited federal resources to reduce the price of outpatient pharmaceuticals and expand health services to our most vulnerable communities. In too many cases, that’s just not what’s happening, and in recent weeks, the media has been shining a spotlight on some of the most cynical deployment of these funds towards profits over patients. <Read More>

HHS Files Brief in 340B Rebate Model Case – March 17, 2025 – The Department of Health and Human Services said its decision to prevent drug companies from implementing a 340B rebate model “was within its statutory authority,” according to a department brief filed March 17 with the U.S. District Court for the District of Columbia. In addition, the brief said the drug companies’ “proposed cash rebate models would have upended the way the 340B Program has operated for more than thirty years” and the agency’s decision to prevent the models from being implemented was “not arbitrary and capricious.” The HHS brief is in cases brought by Eli Lilly, Bristol Meyers Squibb and Novartis. <Read More> 

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Clinical Insights: April 2nd, 2025

New Drug/Vaccine Approval

Qfitlia™ (fitusiran) Injection – New Drug Approval – March 28, 2025 – The US Food and Drug Administration (FDA) has approved Qfitlia™ (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates (ABR) across hemophilia patients with or without inhibitors. <Read More>

Vykat™ XR FDA Approval History – New Drug Approval – March 26, 2025 – Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Vykat XR™ (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). Soleno expects Vykat XR™ to be available in the U.S. beginning in April 2025. <Read More> 

Blujepa™ (gepotidacin) Tablets – New Drug Approval – March 25, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Blujepa™ (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. Discovered by GSK scientists, Blujepa™ is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. <Read More> 

Gozellix® (gallium Ga 68 gozetotide) Injection Kit – New Drug Approval – March 20, 2025 – Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging agent for prostate cancer. <Read More> 

Arbli™ (losartan potassium) Oral Suspension – New Drug Approval – March 13, 2025 – Scienture Holdings, Inc. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli™ (losartan potassium) Oral Suspension, 10 mg/mL. <Read More>

Encelto™ (revakinagene taroretcel-lwey) Intravitreal Implant - formerly NT-501 – New Drug Approval – March 5, 2025 – Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced that the U.S. Food and Drug Administration (FDA), has approved Encelto™ (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel). <Read More> 

New Indication / Dosage / Formulation Approval

Pluvicto® (lutetium lu 177 vipivotide tetraxetan) Injection – New Label Expansion – March 28, 2025 – Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – March 28, 2025 - AstraZeneca’s Imfinzi® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi® as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). <Read More> 

Cabometyx® (cabozantinib) Tablets – New Label Expansion – March 26, 2025 - Exelixis, Inc. (Nasdaq: EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved Cabometyx® (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET). <Read More> 

Egrifta WR™ (tesamorelin) Injection – New Label Expansion – March 25, 2025 - Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename Egrifta WR™. <Read More>

Amvuttra® (vutrisiran) Injection – New Label Expansion – March 20, 2025 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, Amvuttra® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. <Read More> 

Fabhalta® (iptacopan) Capsules – New Label Expansion – March 20, 2025 - Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition. <Read More>

Tremfya® (guselkumab) Injection – New Label Expansion – March 20, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – March 19, 2025 -  The Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda®, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). <Read More> 

Iluvien® (fluocinolone acetonide) Intravitreal Implant – New Label Expansion – March 12, 2025 - ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Iluvien® (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – March 6, 2025 - scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Furoscix® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). <Read More>

neffy® (epinephrine) Nasal Spray – New Label Expansion – March 5, 2025 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years. <Read More> 

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – March 4, 2025 – BeiGene, Ltd. (NASDAQ: ONC; 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-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). <Read More> 

New Drug Shortage

March 28, 2025

March 24, 2025

March 18, 2025

March 17, 2025

March 5, 2025

March 4, 2025

Updated Drug Shortage

March 30, 2025

March 28, 2025

March 27, 2025

March 24, 2025

March 21, 2025

New Drug Recall and Safety Alerts

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Dr. Reddy’s - New Voluntary Recall – March 13, 2025 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States. The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. <Read More>

New Generic/Biosimilar Approval and Launch

Stoboclo® (denosumab-bmwo) Injection - formerly CT-P41 – New Proliaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More> 

Osenvelt® (denosumab-bmwo) Injection - formerly CT-P41 – New Xvegaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More>

Conexxence® (denosumab-bnht) Injection – New Prolia® Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More> 

Bomyntra® (denosumab-bnht) Injection – New Xvegaâ Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More>

Clinical and Pharmacy News

The Key to Solving Medication Errors is at the Intersection of Technology and Standards  – April 1, 2025 – By integrating industry standards into e-prescribing software, prescribing organizations can reduce errors to improve patient outcomes and lessen the burden of medication-related errors on healthcare systems. Here’s a look at the new National Council for Prescription Drug Programs (NCPDP) Sig Standard aimed at improving prescription accuracy. 1.5 million people are affected by medication errors each year, posing a significant risk to patients’ safety and increasing healthcare costs. While providers do everything in their power to prevent medication errors, interoperability and lack of visibility into a patient’s medication history can cause serious challenges. <Read More> 

Medical Gaslighting Tops List of Highest Patient Safety Risks – March 28, 2025 – The risks associated with medical professionals dismissing patient, family and caregiver concerns — also called “medical gaslighting” — ranked highest on an annual list of patient safety concerns compiled by the nonprofit organization ECRI. Insufficient governance of AI in health care, the viral spread of medical misinformation, and medical errors and delays in care resulting from cybersecurity breaches also were listed as significant concerns. <Read More>

AI Can Help Doctors Give Intravenous Nutrition to Preemies, Stanford Medicine Study Finds  – March 25, 2025 – An algorithm that learned from tens of thousands of nutrition prescriptions for premature babies could reduce medical errors and better identify what nutrients the smallest patients need. Artificial intelligence can improve intravenous nutrition for premature babies, a Stanford Medicine study has shown. The study, which published March 25 in Nature Medicine, is among the first to demonstrate how an AI algorithm can enable doctors to make better clinical decisions for sick newborns. <Read More> 

Pharmacy Benefit Managers Lining Pockets at Expense of Patients, Say Lawmakers – March 25, 2025 – Third-party companies known as pharmacy benefit managers, which administer prescription drug benefits for health insurance plans, employers, and other organizations including governments, are driving up prescription drug costs, putting small pharmacies out of business, and interfering in the relationship between doctors and their patients, says Sen. Rochelle Nguyen, a Democrat from Las Vegas and the sponsor of Senate Bill 316, a measure that seeks to reform PBMs.  Nevadans are being deprived of “life-changing and life-saving prescription drugs and often have to make difficult decisions based on what they can and cannot afford,” Nguyen told members of the Senate Committee on Labor and Commerce during a hearing Monday, adding escalating prescription prices are just one component of high costs. “This isn’t a magic pill that’s going to solve all our health care problems.” <Read More> 

Spending Growth on GLP-1s Outpaces Specialty Drugs: Evernorth Study – March 25, 2025 – Spending on GLP-1 drugs continues to rise, after outpacing trends among specialty drugs for the first time in 2023, according to a new report from Evernorth. Pharmaceutical spending overall has grown significantly in recent years, but it has accelerated since semaglutide earned approval for chronic weight management in 2021. Afterward, the rate of annual growth rose from 2.1% in 2021 to 12.8% in 2024, according to the report. Specialty pharmacy has traditionally been the key source of growth in pharmacy spend. For comparison, in 2019, spending for traditional medications decreased by 5% while spending on specialty drugs grew by 11.5%. <Read More> 

How Health Systems Can Thrive in Navigating the Specialty Pharmacy Landscape  – March 24, 2025 – Specialty pharmacies must meet complex requirements, introducing administrative requirements that can be challenging for health systems to manage internally. Here some strategies that can be employed. The demand for specialty medications is on the rise in the United States as people living with complex health conditions increasingly rely on new treatments and therapies to manage their health. By partnering with an advisory service, health systems can take advantage of established expertise to evaluate and choose from among the breadth and complexity of potential solutions for operating and optimizing an integrated specialty pharmacy. <Read More>

DEA Warns of Electronic Prescription Fraud – March 21, 2025 – The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video. “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.” <Read More> 

Ensitrelvir Reduced the Risk for COVID-19 by 67% – March 14, 2025 – Ensitrelvir, an antiviral being developed to prevent COVID-19, reduced the risk of developing the infection by 67% in uninfected people after exposure to SARS-CoV-2 compared with placebo at day 10, according to results presented at CROI 2025, held in San Francisco (abstract 200). The SCORPIO-PEP (Stopping COVID-19 pRogression with early Protease InhibitOr treatment–Post-Exposure Prophylaxis) trial assessed 2,387 study participants, who were 12 years of age and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment. The participants were exposed to a person living in the household who developed symptomatic COVID-19. In this double-blind trial, study participants were randomly assigned to receive 125 mg of ensitrelvir or placebo, once daily, and began prophylaxis within 72 hours of symptom onset in the household member with COVID-19, according to Frederick Hayden, MD, a professor emeritus at the University of Virginia School of Medicine, in Charlottesville. <Read More> 

340B in the News

The Case for 340B Done Right – March 30, 2025 – The federal 340B Drug Pricing Program, which requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to healthcare organizations that care for many uninsured and low-income patients, is facing intense scrutiny and calls for reform. The program’s intent has always been to stretch limited federal resources to reduce the price of outpatient pharmaceuticals and expand health services to our most vulnerable communities. In too many cases, that’s just not what’s happening, and in recent weeks, the media has been shining a spotlight on some of the most cynical deployment of these funds towards profits over patients. <Read More>

HHS Files Brief in 340B Rebate Model Case – March 17, 2025 – The Department of Health and Human Services said its decision to prevent drug companies from implementing a 340B rebate model “was within its statutory authority,” according to a department brief filed March 17 with the U.S. District Court for the District of Columbia. In addition, the brief said the drug companies’ “proposed cash rebate models would have upended the way the 340B Program has operated for more than thirty years” and the agency’s decision to prevent the models from being implemented was “not arbitrary and capricious.” The HHS brief is in cases brought by Eli Lilly, Bristol Meyers Squibb and Novartis. <Read More> 

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

Contact Us