Clinical Insights: April 17, 2024

New Drug/Vaccine Approval

Komzifti™ (ziftomenib) Capsules - New Drug Approval – November 13, 2025 – The Food and Drug Administration approved ziftomenib (Komzifti™, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. <Read More>

Kygevvi® (doxecitine and doxribtimine) Powder for Oral Solution - New Drug Approval –November 3, 2025 – The U.S. Food and Drug Administration (FDA) approved Kygevvi® (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients who start to show symptoms when they are 12 years old or younger. Kygevvi® received Breakthrough Therapy Designation for this indication. <Read More> 

Lynkuet® (elinzanetant) Capsules - New Drug Approval – October 24, 2025 – Bayer announced the U.S. Food and Drug Administration (FDA) has approved Lynkuet® (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. <Read More>

Javadin™ (clonidine hydrochloride) Oral Solution - New Drug Approval – October 23, 2025 – Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Javadin™ (clonidine hydrochloride) oral solution, the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for the treatment of hypertension in adult patients to lower blood pressure. <Read More> 

Epioxa™ (riboflavin 5’-phosphate) Ophthalmic Solution - New Drug Approval – October 17, 2025 - Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD / Epioxa™ (“Epioxa”) New Drug Application (NDA). Epioxa™ is a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated. <Read More>

Ferabright™ (ferumoxytol) Injection - New Drug Approval – October 16, 2025 - Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Ferabright™ (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. <Read More> 

New Label Expansions

Elevidys® (delandistrogene moxeparvovec-rokl) Suspension for Intravenous Infusion – New Label Expansion – November 14, 2025 - Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced an update to the prescribing information for Elevidys® (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD). <Read More>  

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – November 6, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). Darzalex Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – November 5, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Caplyta® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. <Read More> 

Linzess® (linaclotide) Capsules – New Label Expansion – November 4, 2025 - The U.S. Food and Drug Administration (FDA) has approved Linzess® (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess® is the first treatment approved for IBS-C in pediatric patients. <Read More> 

Stoboclo® (denosumab-bmwo) Injection – New Label Expansion – October 29, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated Stoboclo® (denosumab-bmwo) and Osenvelt® (denosumab-bmwo) as interchangeable biosimilars to the reference products Prolia® (denosumab) and Xgeva® (denosumab), respectively, for all approved indications. <Read More>

Conexxence® (denosumab-bnht) Injection – New Label Expansion – October 29, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence® and Bomyntra® (denosumab-bnht) as interchangeable biosimilars to the reference products, Prolia® (denosumab) and Xgeva® (denosumab), respectively. <Read More> 

Winrevair™ (sotatercept) for Injection – New Label Expansion – October 24, 2025 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for Winrevair™ (sotatercept-csrk) for injection, 45mg, 60mg. Winrevair™, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. <Read More> 

Revuforj® (revumenib) Tablets – New Label Expansion – October 24, 2025 - Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. <Read More> 

Blenrep® (belantamab mafodotin-blmf) Injection – New Label Expansion – October 23, 2025 - GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved Blenrep® (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent. <Read More> 

Omvoh® (mirikizumab-mrkz) Injection – New Label Expansion – October 23, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh® (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC). <Read More> 

Gazyva® (obinutuzumab) Injection – New Label Expansion – October 17, 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 Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. <Read More> 

New Drug Shortage

November 17, 2025

• Montelukast Sodium Tablet, Chewable (Discontinuation)

November 14, 2025

• Ceftazidime Injection (Discontinuation)

• Palonosetron Hydrochloride Injection (Discontinuation)

• Somatropin Injection (Discontinuation)

• Vancomycin Hydrochloride Injection (Discontinuation)

November 13, 2025

• Adalimumab-ryvk Kit (Discontinuation)

• Cetrorelix Acetate Injection (Discontinuation)

• Guanfacine Hydrochloride Tablet, Extended Release (Discontinuation)

November 12, 2025

• Frovatriptan Succinate Tablet (Discontinuation)

November 7, 2025

• Atropine Sulfate Injection (Discontinuation)

• Calcium Chloride Injection (Discontinuation)

• Deferiprone Tablet (Discontinuation)

• Dextrose Monohydrate 50% Injection (Discontinuation)

• Epinephrine Injection (Discontinuation)

• Ketamine Hydrochloride Injection (Discontinuation)

• Lidocaine Hydrochloride Injection (Discontinuation)

• Sodium Bicarbonate Injection (Discontinuation)

Updated Drug Shortage

November 18, 2025

• Metronidazole Injection (Discontinuation)

November 17, 2025

• Flurazepam Hydrochloride Capsule (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

November 14, 2025

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate 5% Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

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

• Furosemide Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Meperidine Hydrochloride Injection (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

November 13, 2025

• Azacitidine Injection (Currently in Shortage)

• Bumetanide Injection (Currently in Shortage)

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

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Liraglutide Injection (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Promethazine Hydrochloride Injection (Currently in Shortage)

• Propranolol Hydrochloride Injection (Currently in Shortage)

• Remifentanil Hydrochloride Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

• Valproate Sodium Injection (Currently in Shortage)

November 10, 2025

• Amino Acid Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate 5% Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Nitroglycerin Injection (Currently in Shortage)

• Sterile Water Irrigant (Currently in Shortage)

New Drug Recall and Safety Alerts

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial by Fresenius Kabi – New Voluntary Recall – November 7, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States. <Read More> 

Potassium Chloride 20 mEq Injection by Otsuka ICU Medical LLC – New Voluntary Recall – November 3, 2025 – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. <Read More> 

New Generic/Biosimilar Approval and Launch

Poherdy™ (pertuzumab-dpzb) Injection - New Perjeta® Biosimilar Approval – November 13, 2025 – The Food and Drug Administration approved Poherdy™ (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta® (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta®. <Read More> 

Clinical and Pharmacy News

Government Shutdown Now Over as Federal Agencies Reopen and Employees Return to Work – November 13, 2025 – With the shutdown finally in the rearview mirror, the focus in the Senate is turning to an upcoming fight over health care, with Democrats hoping to regroup after splintering in the final stages of the showdown. Eight Senate Democrats broke ranks to reach a deal with Republicans to end the shutdown, dashing the party's effort to win an extension of expiring Affordable Care Act tax credits in return for their vote to reopen the government. Now, Democrats face a quick timeline to shift their strategy. <Read More> 

ADHD Medication Recalled Nationwide Because Users Aren’t Getting the Full Effect – November 11, 2025 – A popular ADHD medication is being recalled nationwide because its users won’t be able to get the full effect. According to the Food and Drug Administration, several lots of lisdexamfetamine dimesylate capsules, a generic form of Vyvanse®, are being recalled. The recall was announced Oct. 28. The Board of Pharmacy said the medication failed dissolution tests, writing, “Dissolution is important for drugs to be absorbed and have a physiological effect on the human body; they must be in solution. The impacted capsules would not be able to deliver an optimal level of medicine and may impact the therapeutic efficacy of the product.” <Read More> 

CMS Announces GENEROUS Model to Lower Medicaid Drug Prices – November 6, 2025 – CMS announced the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model, a new drug payment model that will aim to lower prescription drug spending in Medicaid and strengthen the program overall. The GENEROUS model, launching in 2026, will allow participating states to purchase drugs included in the pilot at prices in line with those in other nations, with a goal of increasing access to medications and improving health outcomes among Medicaid beneficiaries. The announcement adds to a recent flurry of Trump administration initiatives aimed at addressing high drug prices in the US, including the Most Favored Nation (MFN) executive order and subsequent drug pricing deals with Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly and Company. <Read More> 

Certain Obesity Drugs Will Cost as Little as $149 And Medicare Will Start Covering Them Under White House Deals – November 6, 2025 – Certain blockbuster obesity drugs will be available for as little as $149 per month and more Medicare enrollees will have access to them under two deals announced Thursday by the Trump administration.The arrangements with drugmakers Eli Lilly and Novo Nordisk, which President Donald Trump foreshadowed in remarks last month, are the latest in the administration’s efforts to lower drug prices. As part of the new deals, the drugmakers have also agreed to match prices to the lowest paid in peer nations for all their drugs in Medicaid as well as for the list prices when their medications first hit the market. They will also offer primary care medicines directly to consumers at discounted prices. <Read More> 

New Data Shows Local Pharmacy Shortages – November 5, 2025 – A new mapping tool from the National Community Pharmacists Association and University of Southern California shows a few  pharmacy shortage areas in the Tri-Cities. At least three suburban and five rural neighborhoods are considered lacking across Carter, Hawkins, Johnson, Sullivan, Unicoi and Washington counties. Southwest Virginia also has three shortage areas between Bristol and Abingdon. These regions are defined by how far people need to travel to reach the nearest pharmacy: more than 10 miles in rural areas, two miles in suburbs and one mile in urban neighborhoods. Community pharmacies are critical access points in their communities, said Dr. Ronna Hauser, senior vice president of policy and pharmacy affairs for the NCPA. <Read More> 

Evaluating Pediatric Medication Errors: A Feasibility Study – November 5, 2025 - In a groundbreaking study published in BMC Pediatrics, researchers have delved into a critical yet often overlooked aspect of pediatric healthcare: medication discrepancies. The research conducted by an experienced team, including Mercümek, Bektay, and Uzuner, among others, sheds light on the alarming inconsistencies that can occur in the medication administered to young patients. The objective of this study was to evaluate the occurrence of medication discrepancies within a pediatric ward, utilizing a novel framework known as the Medication Discrepancy Taxonomy (MedTax). <Read More>  

AFPs Affect Access to Specialty Medications – October 30, 2025 - The use of alternative funding programs (AFPs) significantly reduces the likelihood of beneficiaries accessing needed medications, increases time to treatment, and is associated with more gaps in therapy and adverse clinical outcomes compared with traditional pharmacy benefits. Pharmacists at a dozen health systems presented these new results about AFPs—for-profit third-party vendors used by self-funded employer plans that carve out certain medications as “nonessential health benefits” and attempt to obtain medication from non-health plan sources—in a presentation at AMCP Nexus 2025, in National Harbor, Maryland (poster 138). <Read More> 

Many Unanswered Questions: Will the Trump Administration’s Drug Pricing Deals Result in Any Cost Savings for State Medicaid Programs? – October 29, 2025 - Over the last month, the White House has widely touted pricing agreements from two drug manufacturers — Pfizer and AstraZeneca — which it claims will result in substantial prescription drug cost savings for state Medicaid programs.  According to the White House, under these agreements, the manufacturers will provide “Most Favored Nation (MFN)” prices, based on lower international prices paid by other nations, to all state Medicaid programs.  This follows from a May 2025 executive order promoting MFN pricing. <Read More> 

EmblemHealth taps Prime Therapeutics, Amazon for new Pharmacy Benefit Collaboration – October 29, 2025 - New York-based insurer EmblemHealth is teaming up with Prime Therapeutics to rethink the pharmacy benefit experience for its members. Emblem will tap into Prime's tech stack, which allows real-time referrals for specialty drugs instead of the more traditional network structure. In this model, it encourages competitive pricing for specialty products when ensuring members feel the savings directly, the insurer said in an announcement. <Read More> 

340B in the News

Rage Over Rebates: Hospitals Oppose 340B Pilot Program – November 12, 2025 - The federal government is testing a new method of delivering discounts in a program aimed to help hospitals buy certain drugs at lower prices, and health systems aren’t happy about it. The government is testing a new pilot program that would move from hospitals simply buying the drugs at lower prices in the federal 340B Drug Discount Program. The Health Resources and Services Administration said late last month it’s testing a new program with eight companies that would offer rebates to hospitals after they have purchased the drugs. The agency said it is testing plans from large drug companies including Bristol Myers Squibb, Astra Zeneca, and Novo Nordisk Inc. The pilot program is slated to launch Jan. 1. <Read More> 

340B Rebate Models and Medicare Part D 340B Claims: What 340B Covered Entities Need to Know for 2026 – November 11, 2025 – 340B covered entities should carefully review the approved 340B rebate models and the 2026 Medicare Physician Fee Schedule (MPFS) Final Rule provisions on new CMS processes for identifying Medicare Part D claims for 340B drugs. While the current scope may seem limited or not applicable to certain 340B covered entities, now is the most important time to evaluate the implications of these programs if expanded to all 340B drugs and all 340B covered entities in order to ensure that the concerns of 340B covered entities are appropriately addressed. <Read More> 

New Drug/Vaccine Approval

Jascayd® (nerandomilast) Tablets – New Drug Approval – October 7, 2025 -The U.S. Food and Drug Administration (FDA) approved Jascayd® (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare, serious, and progressive disease with no cure and limited treatments. This is the first new therapy approved in more than 10 years for IPF. <Read More>

Lasix® ONYU (furosemide) Injection – New Drug Approval – October 7, 2025 - Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. Lasix® ONYU can be administered subcutaneously outside the healthcare setting for selected patients, as prescribed by a clinician, without the need for a healthcare professional to administer the drug. <Read More> 

Rhapsido® (remibrutinib) Tablets – New Drug Approval – September 30, 2025 - Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido® is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido® helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment. <Read More> 

Qivigy® (immune globulin intravenous, human-kthm) Solution for Infusion – New Drug Approval – September 26, 2025 - Kedrion Biopharma announced that it has received FDA approval for Qivigy® immune globulin intravenous (human)-kthm 10% liquid, indicated for treatment of adults with primary humoral immunodeficiency (PI)—a serious and often underdiagnosed group of disorders that compromise the immune system’s ability to function effectively. Qivigy® a 10% IVIG therapy, developed in Kedrion’s research labs and produced exclusively by Kedrion through its globally integrated network of facilities in the United States and Italy, addresses the unmet needs of patients with PI. <Read More> 

Clotic® (clotrimazole) Otic Solution – New Drug Approval – September 26, 2025 - Salvat Pharmaceutical Group has announced that the U.S. Food and Drug Administration (FDA) has approved 1% otic clotrimazole, the first targeted treatment for otomycosis, for commercialization in the United States. <Read More> 

Inluriyo™ (imlunestrant) Tablets – New Drug Approval – September 25, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Inluriyo™ (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). <Read More> 

Palsonify™ (paltusotine) Tablets – New Drug Approval – September 25, 2025 - Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) announced that the U.S. Food and Drug Administration (FDA) approved Palsonify™ (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Palsonify™, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly. <Read More> 

Bondlido™ (lidocaine) Topical System – New Drug Approval – September 25, 2025 - MEDRx announced that the U.S. Food and Drug Administration (FDA) has approved “Bondlido™”, a lidocaine patch MEDRx Group and D. Western Therapeutics Institute, Inc. has jointly developed, in adults for relief of pain associated with post-herpetic neuralgia (PHN). Going forward, preparations for the launch will be made, including the selection of sales partners, with sales planned to begin in the US in the first half of 2026. <Read More> 

Forzinity™ (elamipretide hydrochloride) Injection – New Drug Approval – September 19, 2025 - Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Forzinity™ (elamipretide) injection to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms (kg) (approximately 66 pounds). Barth syndrome is a life-limiting pediatric mitochondrial cardioskeletal disease that affects approximately 150 individuals in the United States. <Read More> 

Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection – New Drug Approval – September 19, 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 Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. Keytruda Qlex™ must be administered by a health care provider (HCP). Merck expects to have Keytruda Qlex™ (pronounced key-TRUE-duh Q-lex) available in the U.S. in late September. <Read More> 

Subvenite® (lamotrigine) Oral Suspension – New Drug Approval – September 16, 2025 - OWP Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Subvenite® Oral Suspension, the first and only lamotrigine oral suspension in the United States. This innovative formulation will offer treatment options for patients and healthcare providers by offering a flexible, patient-friendly alternative to tablets. <Read More> 

Enbumyst™ (bumetanide) Nasal Spray – New Drug Approval – September 15, 2025 - Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, announced that the U.S. Food and Drug Administration (FDA) has approved Enbumyst™ (bumetanide nasal spray). Enbumyst™ is indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults. <Read More> 

Inlexzo™ (gemcitabine) intravesical system - formerly TAR-200 – New Drug Approval – September 9, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Inlexzo™ (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy). Inlexzo™, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. <Read More> 

New Label Expansions

Tezspire® (tezepelumab-ekko) Injection – New Label Expansion – October 17, 2025 - Amgen (NASDAQ:AMGN) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) approved Tezspire® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. Tezspire® is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP). <Read More> 

Rinvoq® (upadacitinib) Extended-Release Tablets – New Label Expansion – October 10, 2025 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement for Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). <Read More> 

Uzedy® (risperidone) Extended-Release Injectable Suspension – New Label Expansion – October 10, 2025 - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced that the U.S. Food and Drug Administration (FDA) has approved Uzedy® (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults. <Read More> 

Libtayo® (cemiplimab-rwlc) Injection – New Label Expansion – October 8, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The FDA evaluated Libtayo® under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions. An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026. <Read More> 

Simponi® (golimumab) Injection – New Label Expansion – October 7, 2025 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Simponi® (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. This approval builds on the Simponi® indication for adults living with moderately to severely active UC, which together represents more than one million Americans living with this condition. <Read More> 

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – October 4, 2025 - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. <Read More> 

Zepzelca® (lurbinectedin) Injection – New Label Expansion – October 2, 2025 - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast-growing and aggressive cancer with limited treatment options. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 26, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab) for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). <Read More>  

Evkeeza® (evinacumab-dgnb) Injection – New Label Expansion – September 26, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Evkeeza® (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH). Evkeeza® was initially approved in 2021 for adults and adolescents aged 12 years and older with HoFH based on a placebo-controlled trial showing Evkeeza®, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 19, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), which combined affect approximately three million Americans. <Read More> 

Opzelura® (ruxolitinib) Cream – New Label Expansion – September 18, 2025 - Incyte (Nasdaq: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended. <Read More> 

Vyjuvek® (beremagene geperpavec-svdt) Topical Gel – New Label Expansion – September 12, 2025 - Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced that the United States Food and Drug Administration (FDA) approved a label update for Vyjuvek® (beremagene geperpavec-svdt) that expands the Vyjuvek® eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to Vyjuvek® application and managing wound dressings. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules – New Label Expansion – September 10, 2025 - The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN. <Read More> 

Vonvendi® (von willebrand factor (recombinant)) for Injection– New Label Expansion – September 5, 2025 - Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vonvendi® [von Willebrand factor (Recombinant)], expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. Vonvendi® was previously approved for on-demand and perioperative use in adults with VWD and routine prophylactic use in adults with severe Type 3 VWD receiving on-demand therapy. <Read More> 

New Drug Shortage

October 20, 2025

• Oxaliplatin Injection (Discontinuation)

October 17, 2025

• Elbasvir; Grazoprevir Tablet (Discontinuation)

October 16, 2025

• Pemetrexed Disodium Injection (Discontinuation)

• Vigabatrin Oral Solution (Discontinuation)

• Voriconazole Injection (Discontinuation)

October 10, 2025

• Pemetrexed Disodium Injection (Discontinuation)

October 09, 2025

• Adalimumab-afzb Injection (Discontinuation)

• Omeprazole Delayed Release Capsule (Discontinuation)

Updated Drug Shortage

October 17, 2025

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

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

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

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

October 16, 2025

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

• Azacitidine Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

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

October 15, 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)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Meperidine Hydrochloride 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)

• Rocuronium Bromide Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

October 10, 2025

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

October 09, 2025

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

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

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Eydenzelt® (aflibercept-boav) Injection- New Eylea® Biosimilar Approval – October 9, 2025 - Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Eydenzelt® (aflibercept-boav), biosimilar referencing Eylea® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). <Read More> 

Enoby™ (denosumab-qbde) Injection - New Prolia® Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, EnobyTM (denosumab-qbde) and XtrenboTM (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Xtrenbo™ (denosumab-qbde) Injection - New Xvega® Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, Enoby™ (denosumab-qbde) and Xtrenbo™ (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Aukelso (denosumab-kyqq) Injection - New Xvega® Biosimilar Approval – September 16, 2025 - – Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Bosaya™ (denosumab-kyqq) Injection – New Prolia® Biosimilar Approval – September 16, 2025 - Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Clinical and Pharmacy News

Pharmacy Profession Unites to Publish Guiding Principles for State Policy on Pharmacy Personnel-Administered Vaccines – October 16, 2025 –The Pharmacy-based Vaccine Access Work Group, consisting of representatives from a diverse group of 12 organizations across pharmacy practice settings, jointly published guiding principles for state policy on pharmacy personnel–administered vaccines. This marks an unprecedented level of collaboration between pharmacy professionals, symbolizing a strong commitment from the field of pharmacy to national public health interests. <Read More> 

WHO Warns of Widespread Resistance to Common Antibiotics Worldwide – October 13, 2025 – One in six laboratory-confirmed bacterial infections causing common infections in people worldwide in 2023 were resistant to antibiotic treatments, according to a new World Health Organization (WHO) report launched today. Between 2018 and 2023, antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored, with an average annual increase of 5–15%. Data reported to the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) from over 100 countries cautions that increasing resistance to essential antibiotics poses a growing threat to global health. <Read More> 

Why Pharmacist Burnout is a Patient Safety Issue – October 5, 2025 – Behind every prescription safely dispensed stands a pharmacist making dozens of clinical decisions under mounting pressure. What happens when that pressure becomes unbearable? When the professionals who are the last line of defense against medication harm are pushed to their breaking point, patient safety breaks with them. This crisis is real and it is often invisible. Surveys and workplace reports repeatedly show that large numbers of pharmacists experience burnout and consider leaving the profession. Unlike physician burnout, which has received public attention and resources, pharmacist burnout remains under-recognized by many health care leaders and policymakers. <Read More> 

Pharmacist-Led Community Health Interventions Provide Practical, Effective Treatment for Older Adults – October 3, 2025 – Through community health interventions geared toward older adult populations, clinical pharmacists proved their ability to provide practical and effective guidance on managing patients’ medications and chronic diseases, according to findings from a study published in Pharmacy. Despite the need for further research to understand its long-term impacts, preliminary results from the researchers’ Pharm2Home initiative were significantly promising and could serve as a precursor for the development of more pharmacist-led clinical services. <Read More> 

Government Shutdown Could Disrupt Health Care Access – October 1, 2025 – The government shutdown highlights partisan divisions over health care funding, with Democrats pushing for ACA subsidy extensions and Republicans seeking a separate policy debate. Telehealth and home care services face potential disruptions, impacting rural and mobility-limited patients, with possible shifts back to in-person visits. <Read More> 

Trump Announces ‘TrumpRx’ Site for Discounted Drugs and Deal with Pfizer to Lower Prices – September 30, 2025 – President Donald Trump on Tuesday announced a multipronged effort aimed at lowering drug costs in the United States, including the creation of a “TrumpRx” direct-to-consumer website where Americans can buy medicine at discounted prices and a sweeping deal with Pfizer to reduce the prices of many of its products. “The United States is done subsidizing the health care of the rest of the world,” Trump said at a news conference. “By taking this bold step, we’re ending the era of global price gouging at the expense of American families.” <Read More> 

AstraZeneca to Enter Direct-to-Consumer Discount Prescription Market – September 29, 2025 – Digital prescription medication customers have a new option for low-cost medications that cuts out the middleman. Global pharmaceutical company AstraZeneca will launch AstraZeneca Direct, an online direct-to-consumer platform designed to create a way for eligible patients to gain access to their prescribed medications at a transparent cash price with home delivery, on Wednesday, Oct. 1, 2025. <Read More> 

FDA Alleges Association Between Prenatal Acetaminophen Use and Autism in Children – September 23, 2025 – The FDA has announced that it is initiating the process for a label change—and alerting physicians across the country—reflecting supposed evidence suggesting that the use of acetaminophen (Tylenol®; Kenvue) by pregnant women may be associated with a heightened risk of neurological conditions, including attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), or autism. However, the agency also notes that while numerous studies describe an association between acetaminophen and neurological conditions, a causal relationship has not been established. <Read More> 

Ob/Gyn Group Advises Against Cannabis Use During Pregnancy, Recommends Universal Screening – September 18, 2025 – New guidance from the American College of Obstetricians and Gynecologists advises that people abstain from cannabis use during pregnancy and lactation and recommends that providers ask all of their patients about cannabis use before, during and after pregnancy to help avoid potential risks. <Read More> 

340B in the News

Hospitals' Administrative Burden Under 340B Pilot far Outstrips Government's Estimates, AHA Says – October 2, 2025 – The federal agency overseeing the controversial 340B Rebate Model Pilot Program has “vastly underestimated” how much time and money hospitals obligated to participate will spend on reporting burdens, the American Hospital Association (AHA) wrote in a Tuesday letter. The one-year test run—largely supported by drugmakers and denounced by hospitals—is set to kick off Jan. 1, with the Health Resources and Services Administration (HRSA) set to announce manufacturers’ approved application and rebate plans by Oct. 15. <Read More> 

New Drug/Vaccine Approval

Wayrilz™ (rilzabrutinib) Tablets – New Drug Approval – August 28, 2025 – The US Food and Drug Administration (FDA) has approved Wayrilz™ (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 phase 3 study, in which Wayrilz™ met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. <Read More>

Dawnzera™ (donidalorsen) Injection – New Drug Approval – August 21, 2025 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Dawnzera™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. Dawnzera™ is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. Dawnzera™ 80mg is self-administered via subcutaneous autoinjector once every four (Q4W) or eight weeks (Q8W). <Read More> 

Tonmya™ (cyclobenzaprine hydrochloride) - formerly TNX-102 SL – New Drug Approval – August 15, 2025 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya™ is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya™ is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. <Read More>

Papzimeos™ (zopapogene imadenovec-drba) Injection – New Drug Approval – August 14, 2025 – Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, announced that the US Food and Drug Administration (FDA) has approved Papzimeos™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Papzimeos™ is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos™ full approval, which does not require a confirmatory clinical trial. Papzimeos™ is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. Papzimeos™ is delivered via four subcutaneous injections over a 12-week interval. <Read More>

Brinsupri™ (brensocatib) Tablets – New Drug Approval – August 12, 2025 – Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class Brinsupri™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri™ is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. <Read More> 

Hernexeos® (zongertinib) Tablets – New Drug Approval – August 8, 2025 – Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. <Read More>  

KETARx™ (ketamine hydrochloride) Injection – New Drug Approval – August 7, 2025 – PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, announced the advancement of its ketamine transdermal patch as a next-generation, non-opioid pain relief solution, building on the recent FDA approval of its IV ketamine product (KETARx™). <Read More> 

Modeyso™ (dordaviprone) Capsules – New Drug Approval – August 6, 2025 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. <Read More>

New Label Expansions

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – August 29, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: Leqembi® Iqlik™, pronounced "I Click") for maintenance dosing. Leqembi® Iqlik™ is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. <Read More> 

Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (Comirnaty® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More>

Filspari® (sparsentan) Tablets – New Label Expansion – August 27, 2025 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension – New Label Expansion – August 27, 2025 – Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More> 

Repatha® (evolocumab) Injection – New Label Expansion – August 21, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease. <Read More> 

Wegovy® (semaglutide) Injection – New Label Expansion – August 15, 2025 – The U.S. Food and Drug Administration has approved Wegovy® (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar tissue in the liver). MASH, also known as nonalcoholic steatohepatitis, is a serious liver disease. Wegovy®, which was first approved in 2017, is also approved for obesity or overweight and to reduce cardiovascular events, such as heart attacks, in individuals at high risk of these events. Approximately 6% of U.S. adults (14.9 million people) have MASH, and its prevalence is expanding. <Read More> 

Ajovy® (fremanezumab-vfrm) Injection – New Label Expansion – August 5, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Ajovy® for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. <Read More> 

New Drug Shortage

September 8, 2025

• Sumatriptan Nasal Spray (Discontinuation)

• Vecuronium Bromide Injection (Discontinuation)

September 4, 2025

• Azelastine Hydrochloride; Fluticasone Propionate Nasal Spray (Discontinuation)

August 29, 2025

• Methotrexate Injection (Discontinuation)

August 27, 2025

• Dobutamine Hydrochloride Injection (Discontinuation)

• Dopamine Hydrochloride Injection (Discontinuation)

August 25, 2025

• Bumetanide Injection (Currently in Shortage)

Updated Drug Shortage

September 5, 2025

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Lisdexamfetamine Dimesylate Tablet, Chewable (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

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

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Naltrexone Hydrochloride Tablet (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

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

September 4, 2025

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

• Azacitidine Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

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

• Promethazine Hydrochloride Injection (Currently in Shortage)

September 3, 2025

• Amino Acid Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Nitroglycerin Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

September 2, 2025

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

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

• Morphine Sulfate Injection (Currently in Shortage)

• Naltrexone Hydrochloride Tablet (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

August 29, 2025

• Lidocaine Hydrochloride Solution (Resolved)

New Drug Recall and Safety Alerts

Cyclobenzaprine Hydrochloride Tablets USP 10 mg by Unichem Pharmaceuticals (USA) Inc. – New Voluntary Recall – August 27, 2025 – Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets. <Read More> 

Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL by B. Braun Medical – New Voluntary Recall  – August 19, 2025 - B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container. B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. <Read More> 

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Walgreens Shakeup Sparks Patient Fear as Pharmacies Face More Closures After 295 Shutters – September 8, 2025 – A few months after a definitive agreement signing in March, Walgreens has been officially purchased by private equity firm Sycamore Partners for $10 billion, per a press release. Part of the deal means that Walgreens Boots Alliance and its subsidiaries are split into five separate and privately-owned operations… While the $10 billion was heavily supported by Walgreens shareholders, some industry experts worry that this decision will ultimately lead to more layoffs and closures for the brand, per what they told Healthcare Brew. <Read More>

A Pharmacy Benefit Manager Stopped Covering a GLP-1 for Obesity. Now There’s a Lawsuit – September 6, 2025 – A class-action lawsuit has been filed against CVS Caremark over its decision to stop covering Zepbound®, Eli Lilly’s blockbuster GLP-1 drug to treat obesity. When the major pharmacy benefit manager informed patients about the change this year, it suggested that there was “another covered medication that’s safe and effective for your condition and may cost less”: namely Wegovy®, from Novo Nordisk, with which CVS Caremark announced a partnership just before the change took effect. <Read More> 

The Five Biggest Challenges Facing Retail Pharmacy – August 28, 2025 – Retail pharmacy operators face an array of challenges beyond PBM reform, which many observers say remains the single biggest obstacle to operating successfully in today’s environment. Among the most pressing issues is how the Medicare price negotiations that were included in the Inflation Reduction Act will play out at the retail level. Many retailers are concerned that reimbursement mechanisms might not be adequate to support their cash flow needs. In addition, the reimbursement models that evolve for GLP-1 drugs and other high-cost medications could also pose challenges for retailers. <Read More>

Getting a Covid Shot This Fall Could be a lot More Complicated – August 22, 2025 – The millions of Americans who are used to getting their Covid-19 vaccines at a local pharmacy may face new hurdles this fall depending on where they live and whether federal health officials have decided they qualify. Pharmacists’ authority to vaccinate individuals varies across state lines. In some places, it’s dependent upon a federal advisory process that Health Secretary Robert F. Kennedy Jr. has upended. <Read More> 

Determining if LAAO Will Benefit Patients With Afib Using Novel AI Algorithm – August 16, 2025 – Researchers in Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery in collaboration with Cardiovascular Medicine developed a new artificial intelligence (AI) algorithm to identify patients likely to benefit from transcatheter left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs). This algorithm can help patients with atrial fibrillation (AFib) who need to be referred to a subspecialty for consultation. The findings were published in JACC: Clinical Electrophysiology. <Read More>

Costco to Not Sell Abortion Pill Mifepristone at its US Pharmacy Stores – August 15, 2025 – Costco Wholesale (COST.O), opens new tab said on Thursday it has decided to not sell abortion pill mifepristone across all its U.S. pharmacy stores, citing low demand. "Our position at this time not to sell mifepristone, which has not changed, is based on the lack of demand from our members and other patients, who we understand generally have the drug dispensed by their medical providers," Costco said. The decision comes amid campaigns against the pill by religious activist groups, including Inspire Investing and Alliance Defending Freedom. <Read More> 

House, Senate Bills Would Expand Pharmacists’ Scope of Practice – August 14, 2025 – H.R. 3164, the Ensuring Community Access to Pharmacist Services Act, has been sponsored by Rep. Adrian Smith (R-Neb.). The bill would amend the Social Security Act to allow Medicare payment for pharmacists to evaluate, diagnose and treat patients for a range of illnesses including COVID-19, respiratory syncytial virus (RSV) and streptococcal pharyngitis. The measure also would let pharmacists test and treat patients in response to an unspecified “public health need” related to a public health emergency. <Read More> 

Eli Lilly Accused of Bribing Providers to Prescribe GLP-1RA Drugs – August 13, 2025 – Despite posting record Q2 growth for its blockbuster weight loss and diabetes drug tirzepatide, Eli Lilly is facing legal challenge from a lawsuit filed in Texas that accuses the pharma company of bribing providers to prescribe its drugs.  Attorney General for Texas Ken Paxton and Health Choice Alliance claim Eli Lilly “offered illegal incentives” to medical providers in the southern state so its most profitable drugs, including popular glucagon-like peptide-1 receptor agonist (GLP-1RA) medications tirzepatide, marketed as Mounjaro® and Zepbound®, would be preferentially prescribed to patients. <Read More> 

An AI “Copilot” Can Reduce Prescription Errors That Put Patients at Risk – August 12, 2025 – “Take two aspirin and call me in the morning.” If only prescribing medications were as simple as that. In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct drug and dosage…With several collaborators at Amazon, Bayati developed an AI-based system for translating prescriptions with fewer errors. “An AI approach to this problem is a good choice because it’s capable of seeing patterns in prescription data and could flag prescriptions that match error-related patterns and write error-free ones,” Bayati says. <Read More>

340B in the News

AHA Accuses Drug Companies of Colluding to Impose 340B Rebate Plans – September 9, 2025 – The country’s largest hospital lobby is accusing five major drugmakers of secretly conspiring to transition to a rebate model in 340B, in the latest salvo between providers and pharmaceutical companies over the future of the drug discount program. On Monday, the American Hospital Association sent a letter to the heads of the Federal Trade Commission and the Justice Department’s antitrust division asking them to investigate Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, Sanofi and Novartis for potential collusion. <Read More>

CBO Confirms 340B Drug Pricing Program Increases Costs for Federal Taxpayers – September 9, 2025 –  Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement in response to the Congressional Budget Office’s (CBO) report released September 9th, which confirmed the 340B Drug Pricing Program encourages behaviors that increase federal spending and raise prices for American taxpayers. Some of those behaviors include incentivizing the prescription of more expensive drugs, reducing negotiated rebates for insurers, and increasing vertical integration among facilities. <Read More>