Clinical Insights: January 10, 2024

Clinical Insights: January 3, 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

Wainua™ (eplontersen) Injection – New Orphan Drug Approval – December 21, 2023 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca's Wainua™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. Wainua™ is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector. <Read More> Filsuvez® (birch triterpenes) Topical Gel - formerly Oleogel-S10 – New Drug Approval – December 19, 2023 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced that the U.S. Food and Drug Administration (FDA) approved Filsuvez® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB). Filsuvez® is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy. Filsuvez® joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year. <Read More> Alyglo™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid – New Drug Approval – December 17, 2023 – GC Biopharma USA, Inc. announced that the US Food and Drug Administration (FDA) has approved Alyglo™ (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as “G5107B,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). The Alyglo™ pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. <Read More>

New Indication/Dosage/Formulation Approval

Tarpeyo® (budesonide) – New Label Expansion – December 20, 2023 - Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced that the U.S. Food and Drug Administration (FDA) has approved Tarpeyo® (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Tarpeyo® was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Marking a significant milestone, Tarpeyo® is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function. <Read More> Padcev® (enfortumab vedotin-ejfv) and Keytruda® (pembrolizumab) – New Label Expansion – December 15, 2023 – Astellas Pharma Inc. (TSE:4503) and Pfizer Inc. (NYSE: PFE) announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved Padcev® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with Keytruda® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC. <Read More> Adbry® (tralokinumab-ldrm) Injection – New Label Expansion – December 14, 2023 – LEO Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry® is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the key drivers of AD signs and symptoms. <Read More> Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid and ezetimibe) Tablets – New Label Expansion – December 13, 2023 – Esperion (NASDAQ: ESPR) announced that the U.S. Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for Nexletol® and Nexlizet® to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of Nexlizet® or Nexletol® on cardiovascular morbidity and mortality has not been determined” has also been removed. <Read More>  Trogarzo® (ibalizumab-uiyk) Injection – New Label Expansion – December 12, 2023 – Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, announced that the United States Food and Drug Administration (FDA) has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo® (ibalizumab-uiyk). IV push is a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation and is designed to make Trogarzo® administration easier and more convenient for people with HIV and their health care providers. As a result, more clinics will be able to initiate new patients and provide ongoing treatment. <Read More>

New Drug Shortage

December 28, 2023

December 27, 2023

December 21, 2023

December 20, 2023

December 19, 2023

Updated Drug Shortage

January 02, 2024

December 28, 2023

December 27, 2023

December 22, 2023

December 21, 2023

New Drug Recall and Safety Alerts

4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection by Hospira, Inc. – New Voluntary Recall – December 26, 2023 – Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP Abboject® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® Abboject® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® Abboject® Glass Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection. <Read More> Americaine® 20% Benzocaine Topical Anesthetic Spray by Insight Pharmaceuticals – New Voluntary Recall – December 22, 2023 – Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. <Read More> Bleomycin for Injection, USP 15 Units Single Dose Onco-Tain™ Glass Fliptop Vial by Hospira, Inc. – New Voluntary Recall – December 22, 2023 - Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose Onco-Tain™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial. <Read More>

New Generic/Biosimilar Approval and Launch

Condylox Gel 0.5%® - New Generic Approval – December 4, 2023 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, announced that its partner Padagis US LLC has received final approval from the United States Food & Drug Administration (FDA) on its abbreviated New Drug Application (ANDA) for Podofilox Gel, the first drug product generic to Condylox Gel 0.5%® in the U.S. Podofilox Gel is an antimycotic drug for the topical treatment of external genital and perianal warts. <Read More>

Clinical and Pharmacy News

A Popular Asthma Inhaler is Leaving Pharmacy Shelves. Here's What You Need to Know – December 30, 2023 – Some asthma patients may start out the new year scrambling for their go-to inhaler – at least that's the concern as Flovent, a popular drug, leaves store shelves starting in January. Earlier this year, drugmaker GSK announced it's discontinuing Flovent in 2024. There is a generic version to take its place, but some doctors worry patients could be left in the lurch as they sort out how to get the new medication covered by insurance. <Read More> Controlled Substance Transfers: Ensuring Internal Management From Site to Site – December 22, 2023 – Controlled substance transfers are occurring at a higher rate as health systems create their own ecosystems to combat medication shortages. Whenever medications are purchased from any entity, a process must be followed that allows for tracing the medications with ease. When it comes to controlled substances, every individual vial, syringe, or bag must be easily tracked. When pharmacies order medication from traditional distributors, the process is rather automated and straight forward. However, when alternative or home-grown methods of acquiring controlled substances are utilized, additional review of the ordering process, completion of forms, transportation, and receipt of the medication must be put under the microscope to ensure the Code of Federal Regulations (CFR) Title 21 and state regulations are followed. <Read More> Senate Inquiry Reveals Widespread Flaws in Maintaining Pharmacy Customer Data Privacy – December 22, 2023 – Results of a new inquiry conducted by the Senate Finance Committee revealed major flaws regarding how pharmacy chains protect, or fail to protect, customer data. The inquiry, helmed by Senate Finance Committee Chair Ron Wyden (D, Oregon), Representative Pramila Jayapal (D, Washington), and Representative Sara Jacobs (D, California), found that unless a state law is established that requires it, major pharmacy chains do not need a warrant to share prescription data and other health records with law enforcement agencies. The pharmacies to which these findings apply include household names such as CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, the Kroger Company, Rite Aid Corporation, and Amazon Pharmacy. <Read More> FDA Warns Consumers Not to use Counterfeit Ozempic® (semaglutide) Found in U.S. Drug Supply Chain – December 21, 2023 - FDA continues to investigate counterfeit Ozempic® (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured below. Some counterfeit products may still be available for purchase. <Read More> The Role of Pharmacists in HIV Care Continues to Expand – December 21, 2023 – HIV affects 1.2 million people in the United States. Despite the development of effective agents for treatment and prevention of HIV, current rates of viral suppression, pre-exposure prophylaxis and linkage to care fall short of the goals set by the CDC for ending the HIV epidemic. Additionally, the presence of pharmacists in specialty settings, including HIV, has expanded in recent years. Clinical pharmacists are essential components of the interdisciplinary team by providing comprehensive medication management to this complex patient population. <Read More>

340B in the News

AHA Files Friend-of-the-Court Brief Defending Louisiana 340B Contract Pharmacy Law – December 27, 2023 – AHA filed a friend-of-the-court brief in support of a Louisiana law that prohibits drug companies from denying Louisiana hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. PhRMA and AstraZeneca challenged the state law as preempted by the federal law that created the 340B program, and AHA asserts that their challenge should be rejected. “PhRMA and AstraZeneca cannot demonstrate that Congress intended to create or occupy any field through its 340B legislation,” the brief states. <Read More>


New HRSA 340B Program Resource Asserts Agency’s Position on “Patient” Definition – December 21, 2023 – On December 14, 2023, Health Resources & Services Administration (HRSA) announced a new resource on the 340B Program website compiling resources associated with the 340B Program definition of “patient.” The website is available here. While the HRSA website compiling patient definition resources is new, none of the content is new. The website only provides links to existing HRSA and Apexus materials. The website makes clear that HRSA’s position is that it continues to rely on its 1996 guidance in interpreting the 340B Statute’s use of the term “patient.” The timing of this new resource page in connection with last month’s decision in the Genesis case is likely not coincidental, as many 340B covered entities and other 340B Program stakeholders have been closely evaluating the 340B Program definition of “patient” following that decision. <Read More>


Clinical Insights: July 10th, 2025

New Drug/Vaccine Approval

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

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

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

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

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

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

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

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

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

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

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

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

New Label Expansions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

New Drug Shortage

July 8, 2025

July 1, 2025

June 27, 2025

June 26, 2025

June 24, 2025

June 18, 2025

Updated Drug Shortage

July 8, 2025

July 7, 2025

July 3, 2025

July 2, 2025

July 1, 2025

June 30, 2025

June 27, 2025

June 26, 2025

June 23, 2025

June 20, 2025

New Drug Recall and Safety Alerts

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

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

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

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

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

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

340B in the News

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

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

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


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Clinical Insights: July 10th, 2025

New Drug/Vaccine Approval

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

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

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

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

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

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

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

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

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

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

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

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

New Label Expansions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

New Drug Shortage

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Updated Drug Shortage

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June 20, 2025

New Drug Recall and Safety Alerts

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

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

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

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

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

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

340B in the News

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

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

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


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Clinical Insights: July 10th, 2025

New Drug/Vaccine Approval

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

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

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

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

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

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

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

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

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

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

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

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

New Label Expansions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

New Drug Shortage

July 8, 2025

July 1, 2025

June 27, 2025

June 26, 2025

June 24, 2025

June 18, 2025

Updated Drug Shortage

July 8, 2025

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June 30, 2025

June 27, 2025

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June 23, 2025

June 20, 2025

New Drug Recall and Safety Alerts

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

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

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

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

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

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

340B in the News

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

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

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


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> 

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: 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: 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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Ready to get started?

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

Contact Us

Ready to get started?

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

Contact Us