Clinical Insights: July 24, 2024

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

• Divalproex Sodium Tablet, Delayed Release (Discontinuation)

• Memantine Hydrochloride Tablet (Discontinuation)

• Midodrine Hydrochloride Tablet (Discontinuation)

• Nystatin Topical Powder (Discontinuation)

April 25, 2025

• Liraglutide Injection (Currently In Shortage)

April 24, 2025

• Topiramate Capsule, Extended Release (Discontinuation)

April 23, 2025

• Baclofen Tablet (Discontinuation)

April 22, 2025

• Oxaliplatin Injection (Discontinuation)

Updated Drug Shortage

April 24, 2025

• Atropine Sulfate Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently In Shortage)

• Fentanyl Citrate Injection (Currently In Shortage)

• Heparin Sodium Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Rocuronium Bromide Injection (Currently In Shortage)

April 23, 2025

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Dextrose Monohydrate 50% Injection (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Etomidate Injection (Currently In Shortage)

• Heparin Sodium Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Acetate Injection (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sufentanil Citrate Injection (Currently In Shortage)

April 22, 2025

• Amoxicillin Powder, For Suspension (Currently In Shortage)

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Azacitidine Injection (Currently In Shortage)

• Carboplatin Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently In Shortage)

• Mefloquine Hydrochloride Tablet (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently In Shortage)

• Oxazepam Capsule (Currently In Shortage)

• Streptozocin Powder, For Solution (Currently In Shortage)

April 21, 2025

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Naltrexone Hydrochloride Tablet (Currently In Shortage)

• Sodium Acetate Injection (Currently In Shortage)

April 18, 2025

• Lisdexamfetamine Dimesylate Capsule (Currently In Shortage)

• Lisdexamfetamine Dimesylate Tablet, Chewable (Currently In Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently In Shortage)

• Naltrexone Hydrochloride Tablet (Currently In Shortage)

• Technetium TC-99M Pyrophosphate Kit Injection (Currently In Shortage)

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> 

New Drug/Vaccine Approval

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

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

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

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

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

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

New Indication / Dosage / Formulation Approval

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

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

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

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

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

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

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

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

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

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

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

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – March 4, 2025 – BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). <Read More> 

New Drug Shortage

March 28, 2025

• Carboplatin Injection (Discontinuation)

• Ursodiol Tablet (Discontinuation)

March 24, 2025

• Hydrocortisone Cream (Discontinuation)

• Montelukast Sodium Granule (Discontinuation)

March 18, 2025

• Travoprost Solution/Drops (Discontinuation)

March 17, 2025

• Glipizide Tablet, Extended Release (Discontinuation)

March 5, 2025

• Ibandronate Sodium Injection (Discontinuation)

• Ibutilide Fumarate Injection (Discontinuation)

March 4, 2025

• Amlodipine Besylate; Benazepril Hydrochloride Capsule (Discontinuation)

Updated Drug Shortage

March 30, 2025

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Clindamycin Phosphate Injection (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Dopamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Ketamine Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

March 28, 2025

• Carboplatin Injection (Currently In Shortage)

March 27, 2025

• Lisdexamfetamine Dimesylate Capsule (Currently In Shortage)

March 24, 2025

• Amino Acid Injection (Currently In Shortage)

• Dextrose Monohydrate 10% Injection (Currently In Shortage)

• Dextrose Monohydrate 5% Injection (Currently In Shortage)

• Dextrose Monohydrate 70% Injection (Currently In Shortage)

• Lactated Ringers Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 0.9% Irrigation (Currently In Shortage)

• Sterile Water Irrigant (Currently In Shortage)

• Streptozocin Powder, For Solution (Currently In Shortage)

March 21, 2025

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Nitroglycerin Injection (Currently In Shortage)

New Drug Recall and Safety Alerts

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

New Generic/Biosimilar Approval and Launch

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

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

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

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

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

340B in the News

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

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

New Drug/Vaccine Approval

Miudella® (copper) Intrauterine System – New Drug Approval – February 24, 2025 - Sebela Women’s Health Inc., a part of Sebela Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) granted approval of Miudella® (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. Miudella® is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years. <Read More> 

Ctexli™ (chenodiol) Tablets – New Drug Approval – February 21, 2025 - The U.S. Food and Drug Administration approved Ctexli™ (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli™ is the first FDA-approved drug to treat CTX, a very rare lipid storage disease. <Read More> 

Romvimza™ (vimseltinib) Capsules – New Drug Approval – February 14, 2025 - The Food and Drug Administration approved vimseltinib (Romvimza™, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. <Read More> 

Penmenvy™ (meningococcal groups A, B, C, W, and Y vaccine) Lyophilized Powder for Injection – New Vaccine Approval – February 14, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Penmenvy™ (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD).  <Read More> 

Vimkunya™ (chikungunya vaccine, recombinant) Injection – New Vaccine Approval – February 14, 2025 - Bavarian Nordic A/S (OMX: BAVA) announced that the U.S. Food and Drug Administration (FDA) has approved Vimkunya™ (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older. The FDA approved Vimkunya™ under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. <Read More> 

Gomekli™ (mirdametinib) Capsules and Tablets for Oral Suspension – New Drug Approval – February 11, 2025 - The Food and Drug Administration approved mirdametinib (Gomekliä, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. <Read More> 

Emblaveo™ (avibactam and aztreonam) Lyophilized Powder for Injection – New Drug Approval – February 7, 2025 - AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved Emblaveo™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. <Read More> 

Onapgo™ (apomorphine hydrochloride) Subcutaneous Infusion Device - formerly SPN-830 – New Infusion Device Approval – February 4, 2025 - Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) approved Onapgo™ (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make Onapgo™ available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch. <Read More> 

New Indication / Dosage / Formulation Approval

TNKase® (tenecteplase) Lyophilized Powder for Injection – New Label Expansion – March 3, 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 TNKase® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase® marks Genentech’s second approval for stroke, reinforcing the company's long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase® and Activase® (alteplase). <Read More> 

Odactra® (house dust mite allergen extract) Sublingual Tablets – New Label Expansion – February 27, 2025 - ALK (ALKB:DC / OMX: ALK B) announced that the US Food and Drug Administration (FDA) has approved ALK’s Odactra® tablet for use in young children with house dust mite (HDM) allergy Odactra® is now indicated to treat HDM-induced allergic rhinitis, with or without conjunctivitis, in children aged five through 11, in addition to patients aged 12 through 65. Odactra® is an allergy immunotherapy (AIT) tablet which dissolves under the tongue and helps patients reduce their allergy symptoms and their reliance on symptomatic medication. <Read More> 

Sublocade® (buprenorphine) Sustained-Release Injection – New Label Expansion – February 24, 2025 - Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, announced that the U.S. Food and Drug Administration (FDA) has approved label changes for Sublocade® including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD). Key label changes include:  1) Rapid initiation Protocol: Healthcare providers can now initiate treatment with Sublocade® after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability, 2) Alternative Injection Sites: Sublocade® can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration. <Read More> 

Izervay™ (avacincaptad pegol) Intravitreal Solution – New Label Expansion – February 12, 2025 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for Izervay™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As a result, Izervay™ is now approved without a limitation on duration of dosing—providing physicians and patients with greater flexibility when managing GA. <Read More> 

Evrysdi® (risdiplam) Powder for Oral Solution and Oral Tablets – New Label Expansion – February 12, 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 a New Drug Application (NDA) for an Evrysdi® (risdiplam) tablet for people living with spinal muscular atrophy (SMA). Evrysdi® is the only non-invasive disease-modifying treatment for SMA. The 5 mg Evrysdi® tablet can either be swallowed whole or dispersed in water. <Read More> 

Adcetris® (brentuximab vedotin) Injection – New Label Expansion – February 12, 2025 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. <Read More>  

Susvimo® (ranibizumab) Injection for Intravitreal Use via Ocular Implant – New Label Expansion – February 4, 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 macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide. Susvimo® is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections. Susvimo® is now available to U.S. retina specialists and their patients with DME. <Read More> 

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

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – January 26, 2025 - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: Leqembi®) intravenous (IV) maintenance dosing. Leqembi® is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. <Read More> 

New Drug Shortage

March 4, 2025

• Amlodipine Besylate; Benazepril Hydrochloride Capsule (Discontinuation)

March 3, 2025

• Acyclovir Ointment (Discontinuation)

• Adalimumab-adbm Injection (Discontinuation)

• Bacitracin Ophthalmic Ointment (Currently In Shortage)

• Dapagliflozin; Saxaglipitin Hydrochloride Tablet (Discontinuation)

February 28, 2025

• Methylphenidate Film, Extended Release (Currently In Shortage)

• Pimecrolimus Cream (Discontinuation)

February 26, 2025

• Tolterodine Tartrate Capsule, Extended Release (Discontinuation)

• Tolterodine Tartrate Tablet (Discontinuation)

February 20, 2025

• Silodosin Capsule (Discontinuation)

Updated Drug Shortage

March 4, 2025

• Cromolyn Sodium Concentrate (Currently In Shortage)

• Flurazepam Hydrochloride Capsule (Currently In Shortage)

March 3, 2025

• Methylphenidate Film, Extended Release (Currently In Shortage)

February 28, 2025

• Cefotaxime Sodium Powder, for Solution (Currently In Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

February 27, 2025

• Triamcinolone Acetonide Injection (Currently In Shortage)

February 26, 2025

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine

• Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Clonazepam Tablet (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Quinapril Hydrochloride Tablet (Currently In Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently In Shortage)

• Riluzole Oral Suspension (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

• Sterile Water Injection (Currently In Shortage)

New Drug Recall and Safety Alerts

Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags by Central Admixture Pharmacy Services (CAPS) - New Voluntary Recall – February 24, 2025 - Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of the detection of visible black particulate matter in a single sealed vial of Phenylephrine Hydrochloride. <Read More>

Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq by ICU Medical – New Voluntary Recall – February 13, 2025 – ICU Medical, Inc. is voluntarily recalling one lot each of Potassium Chloride Inj. bags with overwrap labels 10mEq, packaged in cases of Potassium Chloride Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of Potassium Chloride Inj. 20 mEq have incorrect overwrap labels which state Potassium Chloride Inj. 10 mEq. <Read More> 

New Generic/Biosimilar Approval and Launch

Ospomyv™ (denosumab-dssb) Injection – New Prolia® Biosimilar Approval – February 16, 2025 - Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia® and Xgeva® respectively. In addition, the FDA granted a provisional determination for both Ospomyv™ and Xbryk™'s interchangeability designation. <Read More>

Xbryk™ (denosumab-dssb) Injection – New Xgeva® Biosimilar Approval – February 16, 2025 - Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Proliaâ and Xgeva® respectively. In addition, the FDA granted a provisional determination for both Ospomyv™ and Xbryk™'s interchangeability designation. <Read More> 

Merilog™ (insulin aspart-szjj) Injection – New Novolog® Biosimilar Approval – February 14, 2025 - The U.S. Food and Drug Administration approved Merilog™ (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog™, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog™ helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. <Read More>

Clinical and Pharmacy News

ASTRO Issues Clinical Guideline on Radiation Therapy for Anal Cancer – February 27, 2025 - A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance on the use of radiation therapy to treat adult patients with primary squamous cell carcinoma of the anal canal and anal margin. The guideline, ASTRO’s first for anal cancer, is published in Practical Radiation Oncology. Although anal cancer is relatively rare compared with colon or rectal cancers, incidence and mortality rates have risen steadily over the past 2 decades, particularly among adults in their 50s. An estimated 10,540 Americans are diagnosed with anal cancer each year, mostly frequently Black men and White women. Overall, women are more than twice as likely as men to develop the disease. <Read More>

Eli Lilly to Expand US Pharma Manufacturing With Four New Sites – February 27, 2025 – Eli Lilly has announced plans to expand its domestic medicine production in the US by establishing four new pharmaceutical manufacturing sites. The move increases the company’s total US capital expansion commitments to more than $50bn since 2020. Three of the four sites will concentrate on active pharmaceutical ingredients manufacturing, aiming to reshore essential small molecule chemical synthesis capabilities and reinforce the company’s supply chain. <Read More> 

How AI Drug Manufacturing is Changing the Game – February 26, 2025 – In drug discovery, companies face a long timeline and steep costs to receive drug approvals. The likelihood of getting to market successfully is less than 10%, according to a 2022 study. “Even small advancements in time-to-lead optimization and improvements in the likelihood of clinical success are important to addressing the thousands of diseases that today have no known treatment or cure,” writes Anthony Costa, NVIDIA director of digital biology, in a HealthTech article. Artificial intelligence helps with process control during drug production and can speed up time to market. Drug discovery and drug manufacturing are both part of pharma AI. <Read More> 

J&J Sues Samsung Bioepis Over ‘Surreptitious’ Breach of Stelaraâ Biosimilar Contract – February 25, 2025 – Johnson & Johnson (J&J) has sued Samsung Bioepis over a ‘concealed plan’ to supply an unnamed health conglomerate with a private label biosimilar version of blockbuster Stelera (ustekinumab). According to the lawsuit filed on 24 February in New Jersey, J&J alleges that Samsung Bioepis has conducted a “surreptitious and deliberate breach” that “threatens irreparable harm to Janssen” in the time since the existing settlement was reached. Developed by subsidiary Janssen, now J&J Innovative Medicine, Stelara has been J&J’s top selling drug since 2019, bringing in peak sales of $11bn in 2023. It is used to treat multiple inflammatory skin and bowel conditions. <Read More> 

How Modern Technology is Shaping the Future of Pharmacy Benefit Management – February 24, 2025 – The pharmacy benefits management (PBM) industry is at a turning point. While 70% of the market still relies on decades-old systems from the big three PBMs, modern technology is quickly transforming the landscape.  ’s cloud-based platforms provide real-time data, advanced analytics and seamless integration into the broader healthcare ecosystem. These innovations enable health plans to respond faster, improve member adherence and optimize benefit management. The shift to modern technology is redefining how organizations manage pharmacy benefits. <Read More> 

FDA Declares End to Semaglutide Shortage; Clock Ticking on Compounded Versions – February 24, 2025 – In the wake of the FDA’s Feb. 21, 2025 announcement declaring an end to the semaglutide (Ozempicâ/Wegovyâ, Novo Nordisk) shortage, stakeholders in the compounding arena offered their take on the agency’s decision and how it may affect patients’ ability to access—and afford—the blockbuster weight-loss medication. The most immediate result of the action will be to dramatically limit the ability of compounding pharmacies to make their own versions of semaglutide. The FDA announcement gave 503A compounders 60 calendar days to stop production of “essentially a copy” of the GLP-1 medications until April 22 this year; 503B compounders were given 90 days, until May 22. <Read More> 

Twenty Drug Interactions You Should Know About – February 21, 2025 – One of the scariest moments of my life happened in 2022 when my father, Tom Donvito, then 75 and unaware of any allergies, experienced an anaphylactic reaction to a hornet sting. After he passed out, my panicked mother called 911, but when the emergency medical technicians arrived, the shot of epinephrine they gave my dad didn’t work – and neither did the second. Why? My dad was on beta blockers, which reduce the effectiveness of epinephrine. Luckily, doctors were able to stabilize him at the hospital. Looking back now, my father doesn’t remember if there was a warning on the safety insert that came with his beta blockers. The EMTs didn’t ask if he was on beta blockers either. <Read More>  

Amazon Joins Forces With Memorial Sloan Kettering for AI-Powered Drug Discovery – February 19, 2025 – Amazon Web Services (AWS) and US-based Memorial Sloan Kettering Cancer Center (MSK) have announced a partnership to leverage artificial intelligence (AI), high-performance computing (HPC), and cloud technology to accelerate cancer research and drug discovery. AWS is one of the world’s largest cloud providers, recently reporting a $107.6bn in segment sales in 2024. The partnership will focus on building a longitudinal data resource for cancer research at MSK, a cancer treatment and research institution based in New York City. <Read More>

How PBMs Limit Access to MS Therapies – February 18, 2025 - The rising cost of specialty medications has long been a challenge for patients with chronic diseases, particularly those living with multiple sclerosis. The Federal Trade Commission’s January 2025 report sheds light on how pharmacy benefit managers are driving up prices, increasing barriers to access, and limiting competition in the specialty drug market. According to the report, pharmacy benefit managers (PBMs) marked up specialty generic drugs by hundreds or even thousands of percent, generating $7.3 billion in revenue over five years. This price inflation disproportionately affects multiple sclerosis (MS) patients, who rely on specialty generics such as Ampyraâ to manage symptoms and maintain their quality of life. However, instead of benefiting from the cost savings generics are supposed to offer, these patients often find their medications out of reach. <Read More> 

Pharmacy Benefit Managers Raised Prices by Over 1,000% on Specialty Drugs – February 14, 2025 – Reporters covering the cost of prescription drugs should be aware of two reports from the Federal Trade Commission on pharmacy benefit managers (PBMs): the first on July 9 and the second on Jan. 14. In the latest report, “Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers,” the FTC staff reported that the three largest PBMs drove up the price of specialty generic drugs for patients with cancer, multiple sclerosis, HIV and pulmonary hypertension by more than 1,000% in some cases and by hundreds of percent in other cases. Together, the nation’s three largest PBMs manage 79% of all prescription drug claims for some 270 million Americans, the FTC staff noted in the July report, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.” <Read More> 

The Remarkable Evolution of HIV/AIDS Treatment – February 14, 2025 – HIV/AIDS was a death sentence. Until LGBT people, people living with HIV, and allies demanded action and pushed the scientific establishment to address the crisis. What followed is nothing short of extraordinary. First came the discovery that AZT (azidothymidine), a drug previously abandoned as a failed cancer treatment, suppressed HIV replication in a petri dish without killing normal cells. Under significant pressure from activists and the public, the FDA fast-tracked testing and review, and approved the drug to treat AIDS in 1987. It worked. <Read More> 

LAAO or DOAC? Mayo Clinic AI Helps Guide Treatment of AFib Patients – February 14, 2025 – Researchers have developed a new artificial intelligence (AI) algorithm that can identify atrial fibrillation (AFib) patients who may benefit from left atrial appendage occlusion (LAAO). The group shared its findings in JACC: Clinical Electrophysiology. “Lifelong oral anticoagulation is recommended for stroke prevention in most patients with AFib, and clinical guidelines recommend direct oral anticoagulant (DOAC) in preference to warfarin in most patients,” wrote first author Che Ngufor, PhD, an AI specialist with Mayo Clinic, and colleagues. “However, oral anticoagulation increases the risk of bleeding and the adherence to lifelong drug therapy is poor, leaving many patients undertreated. Transcatheter LAAO offers an attractive alternative to lifelong drug therapy, but how to select the best candidates for LAAO remains unclear in everyday clinical practice.” <Read More> 

Identifying Weak Planks on the Bridge to Medication Safety – February 12, 2025 – A new review of all 50 state boards of pharmacy regulations by the Institute for Safe Medication Practices has shown that only one or two boards provided detailed guidance for pharmacy drug labeling, ISMP presenters noted at the NASP 2024 Annual Meeting & Expo, in Nashville, Tenn. “Most boards have just generalized, high-level suggestions outside listing requirements for a legal label,” said Jennifer Young, PharmD, BCPS, CSP, a medication safety specialist with ISMP, who noted that an ISMP fellow prepared the pharmacy board review in preparation for the NASP presentation. “I’ve worked in a variety of places in my career, and in each pharmacy, sometimes each store, they had their own preferences and nuances.” <Read More>

340B in the News

The 340B Reimbursement Battle: What Hospitals and Insurers Need to Know – February 12, 2025 – The U.S. Supreme Court’s ruling in American Hospital Association (“AHA”) v. Becerra (2022) sent shockwaves through the 340B drug pricing program when it held that CMS’ reduction of reimbursement for drugs purchased under the 340B program was not permitted by law. The Supreme Court chose not to address potential remedies and remanded the case back to the D.C. District Court for further proceedings on how to correct the underpayments. Instead of vacating the unlawful reimbursement rates, the District Court decided to remand without vacatur, allowing HHS the opportunity to remediate its underpayments. AHA v. Becerra (2023). <Read More>