Clinical Insights: March 20, 2024

Clinical Insights: April 17, 2024

Clinical Insights: April 3, 2024

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

New Drug/Vaccine Approval

Voydeya™ (danicopan) Tablets – New Drug Approval – March 29, 2024 – Voydeya™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). Voydeya™ is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris® (ravulizumab) or Soliris® (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor. <Read More>  Vafseo® (vadadustat) Tablets – New Drug Approval – March 27, 2024 – Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo® is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo® is now approved in 37 countries. <Read More> Winrevair™ (sotatercept) for Injection – New Orphan Drug Approval – March 26, 2024 – Merck (NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: Winrevair™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. Winrevair™ was previously granted Breakthrough Therapy Designation by the FDA. Winrevair™ is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. <Read More> Opsynvi® (macitentan and tadalafil) Tablets – New Orphan Drug Approval – March 22, 2024 – Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. Opsynvi® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. Opsynvi® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets. <Read More> Duvyzat™ (givinostat) Oral Suspension – New Orphan Drug Approval – March 21, 2024 – The U.S. Food and Drug Administration approved Duvyzat™ (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat™ is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle. <Read More> Tryvio™ (aprocitentan) Tablets – New Drug Approval – March 20, 2024 – Idorsia Ltd (SIX: IDIA) announced that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of Tryvio™ is 12.5 mg orally once daily, with or without food. <Read More>

New Indication/Dosage/Formulation Approval

Vemlidy® (tenofovir alafenamide) Tablets – New Label Expansion – March 27, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. <Read More> Elahere® (mirvetuximab soravtansine-gynx) Injection – New Label Expansion – March 22, 2024 – AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Elahere® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as Elahere®. <Read More> Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid and ezetimibe) Tablets – New Label Expansion – March 22, 2024 – Esperion (NASDAQ: ESPR) announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for Nexletol® (bempedoic acid) Tablets and Nexlizet® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of Nexletol® and Nexlizet® either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients. <Read More>  Ultomiris® (ravulizumab-cwvz) Injection – New Label Expansion – March 22, 2024 – Ultomiris® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval by the US Food and Drug Administration (FDA) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were published in the Annals of Neurology. In the trial, Ultomiris® was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial. <Read More> Ixinity® (coagulation factor IX (recombinant)) for Injection – New label Expansion – March 22, 2024 – Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) announced that the US Food and Drug Administration (FDA) recently approved Medexus's supplemental Biologics License Application (sBLA) for Ixinity® [coagulation factor IX (recombinant)] for the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of age with hemophilia B. Ixinity®, an intravenous recombinant factor IX therapeutic, is now approved for use in all patients with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. <Read More> Iclusig® (ponatinib) Tablets – New Label Expansion – March 19, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This accelerated approval application was granted Priority Review and evaluated under the Real-Time Oncology Review (RTOR) program, an FDA initiative designed to expedite the delivery of cancer medicines by allowing components of an application to be reviewed before submission of the complete application. <Read More> Spevigo® (spesolimab-sbzo) Injection – New Label Expansion – March 18, 2024 – Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved Spevigo® (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing ≥40 kg. This approval follows the Chinese National Medical Products Administration’s (NMPA) recent approval of Spevigo® for the reduction of occurrence of generalized pustular psoriasis (GPP) in adolescents from 12 years of age with a body weight ≥40 kg and adults. Spevigo® is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP. <Read More>

New Drug Shortage

March 28, 2024

March 27, 2024 

March 26, 2024

March 25, 2024

March 22, 2024

Updated Drug Shortage

April 02, 2024

April 01, 2024

March 29, 2024

March 28, 2024

March 25, 2024

New Drug Recall and Safety Alerts

Atovaquone Oral Suspension, USP 750 mg/5 mL by AvKARE, LLC. – New Voluntary Recall – April 1, 2024 - AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. <Read More> Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) by Eugia US LLC (f/k/a AuroMedics Pharma LLC) – New Voluntary Recall – March 28, 2024 – Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating inside of the vial. <Read More> Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL by Amneal Pharmaceuticals, LLC. – New Voluntary Recall – March 27, 2024 – Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Biden-Harris Administration Furthers Medicare Drug Price Negotiations, Releases New Data on How the President’s Historic Law Lowers Health Care Costs for Women – April 2, 2024 – The Inflation Reduction Act’s Medicare drug price negotiations and other provisions will lower the cost of prescription drugs for millions of women. The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. Also, HHS announced that the Centers for Medicare & Medicaid Services (CMS) responded to counteroffers from all manufacturers participating in Medicare drug price negotiations – which the Inflation Reduction Act made possible – and invited them to participate in further discussions. <Read More>  Highly Pathogenic Avian Influenza A (H5N1) Virus Infection Reported in a Person in the U.S. – April 1, 2024 – A person in the United States has tested positive for highly pathogenic avian influenza (HPAI) A(H5N1) virus (“H5N1 bird flu”), as reported by Texas and confirmed by CDC. This person had exposure to dairy cattle in Texas presumed to be infected with HPAI A(H5N1) viruses. The patient reported eye redness (consistent with conjunctivitis), as their only symptom, and is recovering. The patient was told to isolate and is being treated with an antiviral drug for flu. This infection does not change the H5N1 bird flu human health risk assessment for the U.S. general public, which CDC considers to be low. <Read More> Study: ‘Gamechanger’ Diabetes Drugs Cost up to 400 Times More Than Needed – March 28, 2024 – Drug companies are pricing diabetes medicines at almost 400 times the level necessary to make a profit, according to a new study. Researchers said it would also be possible for modern insulin pens, which are safer and offer more accurate doses than vials and syringes, to be used even in low-income countries if pharmaceutical firms “put people before their astronomical profits”. A new generation of diabetes drugs known as GLP-1 receptor agonists (GLP-1s) include Novo Nordisk’s Ozempic® (semaglutide), taken by some celebrities as a weight-loss aid, and Eli Lilly’s Trulicity® (dulaglutide). They are now a standard part of treatment in high-income countries, but are unaffordable in many parts of the world despite rising rates of the condition. <Read More> ASCO Updates Guidelines on Vaccines in Patients with Cancer – March 27, 2024 – The American Society of Clinical Oncology (ASCO) recently issued a new clinical practice guideline, “Vaccinations of Adults with Cancer,” updating its recommendations for patients with cancer of which vaccines to receive. For adult patients of all ages, the guideline recommends: 1) Influenza vaccine annually, 2) COVID-19 vaccine according to the recommended CDC schedule, 3) Tdap or Td vaccine once, followed by a booster every 10 years, 4) Two doses of recombinant zoster vaccine at least 4 weeks apart, 5) One dose of PCV20 pneumococcal vaccine or 1 dose of PCV15 followed by PPSV23 8 weeks later. <Read More>  The Truth About Compounded GLP-1s That Doctors Need to Know – March 26, 2024 – Meanwhile, the APC statement notes, Novo Nordisk and Eli Lilly have sued compounding companies in several states, questioning, among other things, the purity and potency of some compounded products. There are different designations for compounding pharmacies: 503A and 503B. 503As are state-licensed pharmacies and physicians, and 503B pharmacies are federally regulated outsourcing facilities that are strictly regulated by the FDA. This regulation, established following a 2012 fungal meningitis outbreak linked to a compounding pharmacy, ensures higher-quality control and oversight, especially for medications intended for intravenous or epidural use. These standards exceed those required for subcutaneous injections like GLP-1 analogs. <Read More> FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects – March 26, 2024 – The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law. Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. <Read More>

340B in the News

Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future. – March 26, 2024 – Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1st to submit comments to legislators regarding the Discussion Draft Explanatory Statement and Supplemental RFI (the “RFI”) of the “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act” (the “Sustain 340B Act”). This bipartisan legislative discussion draft was released by the Senate 340B Working Group (the “Working Group”) earlier this year, to update the 340B Program. <Read More>


Clinical Insights: June 10th, 2026

New Drug/Vaccine Approval

Xocova® (ensitrelvir) Tablets – New Drug Approval – May 29, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova® (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. This approval introduces the first and only oral option to help prevent COVID-19 after exposure in the current therapeutic landscape, addressing a critical gap in prevention. Xocova® is a five-day oral regimen with three tablets taken on day one and one tablet taken on days two through five. The approval occurred ahead of the Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026. <Read More> 

Zaynich™ (cefepime and zidebactam) Powder for Injection – New Drug Approval – May 29, 2026 - Wockhardt announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. Zaynich™ previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. <Read More>

Decnupaz™ (pivekimab sunirine-pvzy) Lyophilized Cake for Injection – New Drug Approval – May 27, 2026 – The Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz™, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Efficacy was evaluated in CADENZA (NCT03386513), a multicenter, open-label, single-arm clinical trial that included adult patients with treatment-naïve BPDCN (N=33) or relapsed or refractory BPDCN (N=51), without evidence of active central nervous system disease. <Read More> 

Hepcludex® (bulevirtide-gmod) Lyophilized Powder for Injection – New Drug Approval – May 22, 2026 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. <Read More>

Differin® Epiduo® Acne Gel (adapalene and benzoyl peroxide) Topical Gel – New Drug Approval – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. <Read More>  

Baxfendy™ (baxdrostat) Tablets – New Drug Approval – May 15, 2026 – AstraZeneca’s Baxfendy™ (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. <Read More>

Trimbow® (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol – New Drug Approval – May 14, 2026 – Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, announced that the U.S. Food and Drug Administration has approved Trimbow® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G; 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg) for the maintenance treatment of asthma in adults. <Read More> 

Beqalzi™ (sonrotoclax) Tablets – New Drug Approval – May 13, 2026 – BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Beqalzi™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. <Read More>

New Label Expansions

Hympavzi® (marstacimab-hncq) Injection – New Label Expansion – Patient Population Altered: June 8, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi® (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. Hympavzi® is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder – New Labl Expansion – Patient Population Altered: May 29, 2026 - MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza® (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – New Indication: May 28, 2026 - The Food and Drug Administration approved durvalumab (Imfinzi®, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). <Read More> 

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – New Indication: May 22, 2026 - AstraZeneca and Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. <Read More> 

Linzess® (linaclotide) Capsules - New Label Expansion – Patient Population Altered: May 21, 2026 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the use of Linzess® (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC). Linzess® was previously approved for pediatric patients 6 years and older with FC. <Read More> 

Tecentriq® (atezolizumab) Injection - New Label Expansion – New Indication: May 15, 2026 - Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay. <Read More> 

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection - New Label Expansion – New Indication: May 15, 2026 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively. <Read More> 

Fasenra® (benralizumab) Injection - New Label Expansion – New Indication: May 13, 2026 - AstraZeneca’s Fasenra® (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. The approval by the US Food and Drug Administration (FDA) was based on positive results from the NATRON Phase III trial that evaluated the efficacy and safety of Fasenra® in patients with HES. <Read More> 

Inqovi® (decitabine and cedazuridine) Tablets - New Label Expansion – New Indication: May 13, 2026 - Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved Inqovi® (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy. Inqovi® in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. <Read More>

New Drug Shortage

June 08, 2026

June 05, 2026

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June 01, 2026

May 27, 2026

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May 15, 2026

May 14, 2026

Updated Drug Shortage

June 09, 2026

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June 05, 2026

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June 03, 2026

June 01, 2026

May 27, 2026

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May 22, 2026

May 21, 2026

New Drug Recall and Safety Alerts

DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL by Sun Pharmaceutical Industries, Inc. (Sun Pharma) – New Voluntary Recall – May 13, 2026 - Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials is being recalled due to the detection of glass particles in some vials during production. <Read More> 

New Generic/Biosimilar Approval and Launch

Immgolis™ and Immgolis Intri™ (golimumab-sldi) Injection – New Biosimilars for Simponi® and Simponi Aria® – May 15, 2026 – FDA approved Immgolis™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponiâ (golimumab) and Immgolis Intri™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria® (golimumab). Immgolis™ and Immgolis Intri™ are the first biosimilars approved for Simponi® and Simponi Aria, respectively. Immgolis™ is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri™ is administered as an intravenous infusion prepared from a single dose vial. <Read More> 

Clinical and Pharmacy News

First-ever Guideline on Cardiovascular-Kidney-Metabolic Syndrome Issued – June 9, 2026 - The first-ever clinical practice guideline on cardiovascular-kidney-metabolic (CKM) syndrome from the American Heart Association and the American College of Cardiology details staging to assess how a person’s kidneys, metabolism and heart are functioning. Higher stages of CKM syndrome are associated with a greater burden of serious health conditions, such as Type 2 diabetes, chronic kidney disease, and a higher risk of cardiovascular disease and mortality. <Read More> 

New GLP-3 Drug Significantly Slashes Both Weight and Blood Sugar Levels in Phase III Trial – June 9, 2026 - Over the past few years, GLP-1 drugs have transformed the treatment landscape for obesity and type 2 diabetes… Now, researchers are exploring whether the next wave of therapies can go even further. A Phase III clinical trial, TRANSCEND-T2D-1, evaluated retatrutide in adults with type 2 diabetes. Unlike GLP-1 drugs, retatrutide belongs to an emerging class known as GLP-3 agonists, which target GIP, GLP-1 and glucagon receptors simultaneously to amplify metabolic benefits. <Read More>

The Hidden Reimbursement Crisis in Medicare’s Drug Price Negotiation Program – June 8, 2026 - Dispensing-fee reality under Part D ($0.00-$7.15; mean approximately $0.65) is misaligned with measured cost of dispensing (approximately $15 retail; approximately $90 specialty), embedding predictable losses into Medicare Transaction Facilitator participation. Pharmacy benefit manager–negotiated fee-setting, with limited Centers for Medicare & Medicaid Services (CMS) specificity, predictably drives below-cost reimbursement and risks accelerating independent pharmacy contraction and reduced beneficiary choice. <Read More> 

First Expert Recommendations for Safe GLP-1 Use in Type 1 Diabetes – June 5, 2026 - Off-label use of medications like Ozempic®, Wegovy®, Mounjaro®, and Zepbound® is becoming increasingly common to address weight management, insulin resistance, and diabetes related complications in type 1 diabetes. New expert recommendations provide a framework for safe use while large trials are ongoing. <Read More> 

A Painful Side Effect of Statins Explained After Decades of Mystery – June 2, 2026 – For millions of people, statins are a daily shield against heart disease. But around 10 percent of those who take statins to lower cholesterol experience a mysterious, painful side effect that causes many to discontinue these potentially life-saving medicines. Scientists have recently found one possible reason why. Research from Columbia University and the University of Rochester in the US revealed a potential culprit: a tiny calcium gate inside muscle cells that statins may force open. <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – June 1, 2026 - In the span of a single week in late January and early February 2026, 3 federal actions—by Congress, the Department of Labor (DOL), and the Federal Trade Commission (FTC)—brought transparency efforts to the forefront of drug pricing policy. Whereas recent reforms have centered on prices set by pharmaceutical companies, this new wave of provisions shifts the focus to the role of pharmacy benefit managers (PBMs). We examine the drug pricing issues that transparency policies aim to address, how they may accomplish those aims, and what conditions are necessary for their success. <Read More> 

From Close Calls to Safer Systems: Rethinking Near Miss Reporting in Healthcare – May 28, 2026 - After decades of focus on improving patient safety, we have seen meaningful progress in key areas like hospital-acquired infections, pressure ulcers, and falls. However, across all disciplines, clinical and administrative leaders, frontline staff, and key industry stakeholders continue to see preventable harm persist. Around one in ten patients experience harm in their care journey, and more than 50 percent of that harm is preventable. <Read More> 

CVS Caremark Will Cover Lilly’s Weight Loss Drug Zepbound Again After Patient Backlash – May 28, 2026 - CVS Caremark will resume covering the weight loss drug Zepbound this year after it removed it from its list of covered medications last year, drugmaker Eli Lilly said Thursday. CVS Caremark is one of the country’s largest pharmacy benefit managers, deciding which medications millions of people in the U.S. can get through insurance and how much they pay out of pocket. <Read More> 

Millions of Insulin Pods may be Leaking, FDA Warns: Here's how to Check Yours – May 27, 2026 - An estimated 7 million Omnipod insulin pods are under a voluntary Medical Device Correction due to a manufacturing error that can make the pods under-deliver insulin. The alert, issued by Insulet Corporation, Inc. and the FDA on May 26, comes after 24 reports of "serious adverse events" including hospitalization caused by high blood glucose levels due to the under-delivery. No deaths have been reported. <Read More> 

340B in the News

Eli Lilly Moves to Deny 340B Pricing Over Data Requirements; AHA Urges Federal Action – June 2, 2026 - Eli Lilly said June 1 it will deny 340B Drug Pricing Program discounts to providers that do not meet its documentation requirements by next week. In a statement shared with media last night, AHA President and CEO Rick Pollack said, “Eli Lilly will soon take the extraordinary step of denying 340B discounts under its unlawful claims data policy. This decision will undoubtedly harm America’s most vulnerable patients and communities, forcing hospitals to divert resources away from care and towards onerous and expensive administrative burdens. <Read More> 

The 340B Contract Pharmacy Market in 2026: A Maturing Industry Dominated by Big Chains and PBMs – June 2, 2026 – It’s time for Drug Channels Institute’s latest exclusive analysis of the 340B contract pharmacy market, which continues to boom along with the overall program’s expansion. However, our 2026 analysis finds that the contract pharmacy market is now entering a more mature phase characterized by consolidation, slower growth, and increasing dominance by the industry’s largest participants. <Read More> 

Audit Pressure Mounts for 340B Programs as Compliance Platforms Aim to Keep Up – May 27, 2026 - HRSA FY2025 audits showed 49% adverse findings, driven mainly by administrative inaccuracies; incorrect OPAIS records appeared in 75% of adverse audits, underscoring persistent master-data governance gaps. Risk-targeted audits (~90%) elevate exposure from tips, OPAIS anomalies, contract-pharmacy complexity, and prior findings; a 68% re-audit failure rate amplifies the need for durable remediation. <Read More> 


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Clinical Insights: June 10th, 2026

New Drug/Vaccine Approval

Xocova® (ensitrelvir) Tablets – New Drug Approval – May 29, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova® (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. This approval introduces the first and only oral option to help prevent COVID-19 after exposure in the current therapeutic landscape, addressing a critical gap in prevention. Xocova® is a five-day oral regimen with three tablets taken on day one and one tablet taken on days two through five. The approval occurred ahead of the Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026. <Read More> 

Zaynich™ (cefepime and zidebactam) Powder for Injection – New Drug Approval – May 29, 2026 - Wockhardt announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. Zaynich™ previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. <Read More>

Decnupaz™ (pivekimab sunirine-pvzy) Lyophilized Cake for Injection – New Drug Approval – May 27, 2026 – The Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz™, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Efficacy was evaluated in CADENZA (NCT03386513), a multicenter, open-label, single-arm clinical trial that included adult patients with treatment-naïve BPDCN (N=33) or relapsed or refractory BPDCN (N=51), without evidence of active central nervous system disease. <Read More> 

Hepcludex® (bulevirtide-gmod) Lyophilized Powder for Injection – New Drug Approval – May 22, 2026 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. <Read More>

Differin® Epiduo® Acne Gel (adapalene and benzoyl peroxide) Topical Gel – New Drug Approval – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. <Read More>  

Baxfendy™ (baxdrostat) Tablets – New Drug Approval – May 15, 2026 – AstraZeneca’s Baxfendy™ (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. <Read More>

Trimbow® (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol – New Drug Approval – May 14, 2026 – Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, announced that the U.S. Food and Drug Administration has approved Trimbow® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G; 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg) for the maintenance treatment of asthma in adults. <Read More> 

Beqalzi™ (sonrotoclax) Tablets – New Drug Approval – May 13, 2026 – BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Beqalzi™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. <Read More>

New Label Expansions

Hympavzi® (marstacimab-hncq) Injection – New Label Expansion – Patient Population Altered: June 8, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi® (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. Hympavzi® is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder – New Labl Expansion – Patient Population Altered: May 29, 2026 - MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza® (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – New Indication: May 28, 2026 - The Food and Drug Administration approved durvalumab (Imfinzi®, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). <Read More> 

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – New Indication: May 22, 2026 - AstraZeneca and Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. <Read More> 

Linzess® (linaclotide) Capsules - New Label Expansion – Patient Population Altered: May 21, 2026 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the use of Linzess® (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC). Linzess® was previously approved for pediatric patients 6 years and older with FC. <Read More> 

Tecentriq® (atezolizumab) Injection - New Label Expansion – New Indication: May 15, 2026 - Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay. <Read More> 

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection - New Label Expansion – New Indication: May 15, 2026 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively. <Read More> 

Fasenra® (benralizumab) Injection - New Label Expansion – New Indication: May 13, 2026 - AstraZeneca’s Fasenra® (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. The approval by the US Food and Drug Administration (FDA) was based on positive results from the NATRON Phase III trial that evaluated the efficacy and safety of Fasenra® in patients with HES. <Read More> 

Inqovi® (decitabine and cedazuridine) Tablets - New Label Expansion – New Indication: May 13, 2026 - Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved Inqovi® (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy. Inqovi® in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. <Read More>

New Drug Shortage

June 08, 2026

June 05, 2026

June 04, 2026

June 01, 2026

May 27, 2026

May 21, 2026

May 15, 2026

May 14, 2026

Updated Drug Shortage

June 09, 2026

June 08, 2026

June 05, 2026

June 04, 2026

June 03, 2026

June 01, 2026

May 27, 2026

May 26, 2026

May 22, 2026

May 21, 2026

New Drug Recall and Safety Alerts

DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL by Sun Pharmaceutical Industries, Inc. (Sun Pharma) – New Voluntary Recall – May 13, 2026 - Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials is being recalled due to the detection of glass particles in some vials during production. <Read More> 

New Generic/Biosimilar Approval and Launch

Immgolis™ and Immgolis Intri™ (golimumab-sldi) Injection – New Biosimilars for Simponi® and Simponi Aria® – May 15, 2026 – FDA approved Immgolis™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponiâ (golimumab) and Immgolis Intri™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria® (golimumab). Immgolis™ and Immgolis Intri™ are the first biosimilars approved for Simponi® and Simponi Aria, respectively. Immgolis™ is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri™ is administered as an intravenous infusion prepared from a single dose vial. <Read More> 

Clinical and Pharmacy News

First-ever Guideline on Cardiovascular-Kidney-Metabolic Syndrome Issued – June 9, 2026 - The first-ever clinical practice guideline on cardiovascular-kidney-metabolic (CKM) syndrome from the American Heart Association and the American College of Cardiology details staging to assess how a person’s kidneys, metabolism and heart are functioning. Higher stages of CKM syndrome are associated with a greater burden of serious health conditions, such as Type 2 diabetes, chronic kidney disease, and a higher risk of cardiovascular disease and mortality. <Read More> 

New GLP-3 Drug Significantly Slashes Both Weight and Blood Sugar Levels in Phase III Trial – June 9, 2026 - Over the past few years, GLP-1 drugs have transformed the treatment landscape for obesity and type 2 diabetes… Now, researchers are exploring whether the next wave of therapies can go even further. A Phase III clinical trial, TRANSCEND-T2D-1, evaluated retatrutide in adults with type 2 diabetes. Unlike GLP-1 drugs, retatrutide belongs to an emerging class known as GLP-3 agonists, which target GIP, GLP-1 and glucagon receptors simultaneously to amplify metabolic benefits. <Read More>

The Hidden Reimbursement Crisis in Medicare’s Drug Price Negotiation Program – June 8, 2026 - Dispensing-fee reality under Part D ($0.00-$7.15; mean approximately $0.65) is misaligned with measured cost of dispensing (approximately $15 retail; approximately $90 specialty), embedding predictable losses into Medicare Transaction Facilitator participation. Pharmacy benefit manager–negotiated fee-setting, with limited Centers for Medicare & Medicaid Services (CMS) specificity, predictably drives below-cost reimbursement and risks accelerating independent pharmacy contraction and reduced beneficiary choice. <Read More> 

First Expert Recommendations for Safe GLP-1 Use in Type 1 Diabetes – June 5, 2026 - Off-label use of medications like Ozempic®, Wegovy®, Mounjaro®, and Zepbound® is becoming increasingly common to address weight management, insulin resistance, and diabetes related complications in type 1 diabetes. New expert recommendations provide a framework for safe use while large trials are ongoing. <Read More> 

A Painful Side Effect of Statins Explained After Decades of Mystery – June 2, 2026 – For millions of people, statins are a daily shield against heart disease. But around 10 percent of those who take statins to lower cholesterol experience a mysterious, painful side effect that causes many to discontinue these potentially life-saving medicines. Scientists have recently found one possible reason why. Research from Columbia University and the University of Rochester in the US revealed a potential culprit: a tiny calcium gate inside muscle cells that statins may force open. <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – June 1, 2026 - In the span of a single week in late January and early February 2026, 3 federal actions—by Congress, the Department of Labor (DOL), and the Federal Trade Commission (FTC)—brought transparency efforts to the forefront of drug pricing policy. Whereas recent reforms have centered on prices set by pharmaceutical companies, this new wave of provisions shifts the focus to the role of pharmacy benefit managers (PBMs). We examine the drug pricing issues that transparency policies aim to address, how they may accomplish those aims, and what conditions are necessary for their success. <Read More> 

From Close Calls to Safer Systems: Rethinking Near Miss Reporting in Healthcare – May 28, 2026 - After decades of focus on improving patient safety, we have seen meaningful progress in key areas like hospital-acquired infections, pressure ulcers, and falls. However, across all disciplines, clinical and administrative leaders, frontline staff, and key industry stakeholders continue to see preventable harm persist. Around one in ten patients experience harm in their care journey, and more than 50 percent of that harm is preventable. <Read More> 

CVS Caremark Will Cover Lilly’s Weight Loss Drug Zepbound Again After Patient Backlash – May 28, 2026 - CVS Caremark will resume covering the weight loss drug Zepbound this year after it removed it from its list of covered medications last year, drugmaker Eli Lilly said Thursday. CVS Caremark is one of the country’s largest pharmacy benefit managers, deciding which medications millions of people in the U.S. can get through insurance and how much they pay out of pocket. <Read More> 

Millions of Insulin Pods may be Leaking, FDA Warns: Here's how to Check Yours – May 27, 2026 - An estimated 7 million Omnipod insulin pods are under a voluntary Medical Device Correction due to a manufacturing error that can make the pods under-deliver insulin. The alert, issued by Insulet Corporation, Inc. and the FDA on May 26, comes after 24 reports of "serious adverse events" including hospitalization caused by high blood glucose levels due to the under-delivery. No deaths have been reported. <Read More> 

340B in the News

Eli Lilly Moves to Deny 340B Pricing Over Data Requirements; AHA Urges Federal Action – June 2, 2026 - Eli Lilly said June 1 it will deny 340B Drug Pricing Program discounts to providers that do not meet its documentation requirements by next week. In a statement shared with media last night, AHA President and CEO Rick Pollack said, “Eli Lilly will soon take the extraordinary step of denying 340B discounts under its unlawful claims data policy. This decision will undoubtedly harm America’s most vulnerable patients and communities, forcing hospitals to divert resources away from care and towards onerous and expensive administrative burdens. <Read More> 

The 340B Contract Pharmacy Market in 2026: A Maturing Industry Dominated by Big Chains and PBMs – June 2, 2026 – It’s time for Drug Channels Institute’s latest exclusive analysis of the 340B contract pharmacy market, which continues to boom along with the overall program’s expansion. However, our 2026 analysis finds that the contract pharmacy market is now entering a more mature phase characterized by consolidation, slower growth, and increasing dominance by the industry’s largest participants. <Read More> 

Audit Pressure Mounts for 340B Programs as Compliance Platforms Aim to Keep Up – May 27, 2026 - HRSA FY2025 audits showed 49% adverse findings, driven mainly by administrative inaccuracies; incorrect OPAIS records appeared in 75% of adverse audits, underscoring persistent master-data governance gaps. Risk-targeted audits (~90%) elevate exposure from tips, OPAIS anomalies, contract-pharmacy complexity, and prior findings; a 68% re-audit failure rate amplifies the need for durable remediation. <Read More> 


Read More

Clinical Insights: May 15th, 2026

New Drug/Vaccine Approval

Veppanu™ (vepdegestrant) Tablets – New Drug Approval – May 1, 2026 - Arvinas, Inc. (Nasdaq: ARVN), with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted approval for Veppanu™ (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. This approval marks the first time the FDA has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. <Read More>

Otarmeni™ (lunsotogene parvec-cwha) Suspension for Intracochlear Infusion – New Drug Approval – April 23, 2026 - The U.S. Food and Drug Administration approved Otarmeni™ (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Otarmeni™ is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene. <Read More> 

Idvynso™ (doravirine and islatravir) Tablets – New Drug Approval – April 20, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) approved Idvynso™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. <Read More> 

New Label Expansions

Ocrevus® (ocrelizumab) Injection – New Label Expansion – Patient Population Altered: May 8, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older who weigh 55 pounds (25 kg) or more. <Read More> 

Vyvgart® (efgartigimod alfa-fcab) Injection – New Label Expansion – New Indication Approved: May 8, 2026 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the U.S. Food and Drug Administration (FDA) approved a label expansion for Vyvgart® (efgartigimod alfa-fcab) and Vyvgart Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). <Read More> 

Bizengri® (zenocutuzumab-zbco) Injection – New Label Expansion – New Indication Approved: May 8, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for Bizengri® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. <Read More> 

Jakafi™ (ruxolitinib) Tablets - New Label Expansion – New Dosage Form Approved: May 1, 2026 - Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. <Read More> 

Asceniv™ (immune globulin intravenous, human – slra) Injection - New Label Expansion – Patient Population Altered: April 30, 2026 – ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act for Asceniv™. <Read More> 

Auvelity® (dextromethorphan and bupropion) Extended-Release Tablets – New Label Expansion – New Indication Approved: April 30, 2026 – The U.S. Food and Drug Administration approved an expanded use for Auvelity® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity® in 2022 to treat major depressive disorder in adults. <Read More> 

Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate) Inhalation Aerosol – New Label Expansion – Patient Population Altered: April 27, 2026 – AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult and paediatric patients 12 years of age and older. Breztri® is a single-inhaler that combines the efficacy of corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines with a long-acting muscarinic antagonist (LAMA). <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – Labeling Revision Approved: April 24, 2026 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of Caplyta® (lumateperone) for the prevention of relapse in schizophrenia. <Read More> 

Saphnelo® (anifrolumab-fnia) Injection – New Label Expansion – New Dosage Form Approved: April 24, 2026 – AstraZeneca’s Saphnelo® (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo® Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphneloâ led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy. <Read More>

Dupixent® (dupilumab) Injection – New Label Expansion – Patient Population Altered: April 22, 2026 – The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. This expands the previous approval for Dupixent® in adults and adolescents aged 12 years and older with CSU. <Read More> 

Tzield® (teplizumab-mzwv) Injection – New Label Expansion – New Indication Approved: April 20, 2026 – The US Food and Drug Administration (FDA) has approved the supplemental biologic license application for Tzield® (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. <Read More> 

Stelara® (ustekinumab) Injection – New Label Expansion – Patient Population Altered: April 15, 2026 – the U.S. Food and Drug Administration (FDA) approved Stelara® (ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn’s disease (CD). <Read More> 

Filspari® (sparsentan) Tablets – New Label Expansion – New Indication Approved: April 13, 2026 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved Filspari® (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. Filspari® is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease. <Read More> 

Vabysmo® (faricimab-svoa) Intravitreal Injection – New Label Expansion – Labeling Revision Approved: April 9, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Vabysmo® (faricimab-svoa) for the treatment of macular edema due to retinal vein occlusion (RVO) beyond six months. RVO affects over a million Americans and often involves long-term intravitreal therapy to address the chronic nature of the disease. <Read More> 

New Drug Shortage

May 08, 2026

May 07, 2026

May 06, 2026

May 05, 2026

April 29, 2026

Updated Drug Shortage

May 08, 2026

May 07, 2026

May 05, 2026

May 01, 2026

April 30, 2026

New Drug Recall and Safety Alerts

Lactated Ringer’s Injection, 1L, E7500 by B. Braun Medical, Inc. – New Voluntary Recall – April 28, 2026 - B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have particulate matter in solution. <Read More> 

New Generic/Biosimilar Approval and Launch

Langlara™ (insulin glargine-aldy) Injection – New Lantus® Biosimilar Approval – April 29, 2026 - Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma announced that the U.S. Food and Drug Administration (FDA) has approved Langlara™ (insulin glargine-aldy), as a biosimilar to Lantus® (insulin glargine), for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA has determined that Langlara™ is interchangeable with the reference drug, enabling pharmacists to substitute Langlara™ for Lantus® without prescriber intervention in states that permit such substitution. <Read More> 

Clinical and Pharmacy News

Nearly 3,000 Peer-Reviewed Medical Papers Have Fake Citations, a Columbia Nursing AI-Assisted Audit Finds – May 7, 2026 - A new Columbia University School of Nursing AI-assisted audit reveals nearly 3,000 peer-reviewed medical papers have fake citations that do not exist in scientific databases. The results highlight an alarming trend in academic publishing as the use of AI grows. <Read More> 

Pulmonary Embolism Care Gets Major Update – May 2, 2026 - A new clinical practice guideline has outlined a comprehensive, evidence-based framework for evaluating and managing acute pulmonary embolism in adults. The guideline applies to patients aged 18 years and older and spans the full clinical course, from symptom onset through post-acute follow-up. <Read More> 

Americans’ Challenges With Health Care Costs – April 30, 2026 - For many years, KFF polling has found that the high cost of health care is a burden on U.S. families, and that health care costs factor into decisions about insurance coverage and care seeking. These costs also rank as the top financial worry for adults and their families. This data note summarizes recent KFF polling on the public’s experiences with health care costs. <Read More> 

Prescription Drug Affordability: Examining Select Price Drivers – April 27, 2026 - Prescription drug prices heavily influence the public’s perception of health care affordability. A range of market, regulatory, and structural factors shape the timing and strength of competition in prescription drug markets, including the entry and uptake of generics and biosimilars. Even modest delays contribute to higher spending and slower realization of savings for consumers and taxpayers. This brief examines several drivers of prescription drug costs—as well as the market structures that shape their prices, with a focus on the commercial market—to inform policymakers’ discussions around affordability and broader health care cost pressures on consumers. <Read More> 

A Look at Payers' Attitudes Toward Specialty Drug Management  – April 27, 2026 - Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report. The Pharmaceutical Strategies Group (PSG) on Monday released its annual Trends in Specialty Drug Benefits report, which offers a look at how payers are responding to rising costs for these products and striking a balance between cost management and access. <Read More> 

New Study Underscores IRA’s Successes, Opportunities for Future Reforms – April 23, 2026 - A recent JAMA article found two key Inflation Reduction Act (IRA) prescription drug provisions that took effect in 2024—the elimination of coinsurance for catastrophic coverage and the expansion of the Part D low-income subsidy—improved medication adherence among Medicare beneficiaries. <Read More> 

Updated Endometriosis Guidelines: A Step Forward in Ethical Reproductive Healthcare – April 23, 2026 - New clinical guidelines for the diagnosis of endometriosis are welcome news. The guidelines, recently issued by the American College of Obstetricians and Gynecologists (ACOG), recommend that physicians treat patients as “partners and experts about their own bodies,” aligning with reproductive justice imperatives long overdue in the care of people with this common condition. <Read More>  

340B in the News

ASCO Updates 340B Policy Statement to Expand Access, Improve Transparency – May 6, 2026 - For the first time since 2014, the American Society of Clinical Oncology (ASCO) has updated its policy statement on the 340B Drug Pricing Program. The statement was published in JCO Oncology Practice…The new recommendations included in the policy statement are intended to expand practice eligibility, ensure benefit to the intended patients, and address any potential abuses. <Read More>  

The Fight Over 340B: Why a Little-Known Drug Program Matters for Black and Low-Income Patients – May 6, 2026 - Nearly three miles from the halls of power in Washington, Howard University Hospital operates at the intersection of policy and reality—where decisions made on Capitol Hill carry real consequences for patients and their families. Designated by the federal government as a disproportionate share hospital, Howard reflects the very mission behind the federal 340B drug pricing program. For decades, 340B has allowed safety-net providers to stretch limited resources by purchasing discounted medications and reinvesting those savings into patient care. <Read More>  

Read More

Clinical Insights: May 15th, 2026

New Drug/Vaccine Approval

Veppanu™ (vepdegestrant) Tablets – New Drug Approval – May 1, 2026 - Arvinas, Inc. (Nasdaq: ARVN), with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted approval for Veppanu™ (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. This approval marks the first time the FDA has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. <Read More>

Otarmeni™ (lunsotogene parvec-cwha) Suspension for Intracochlear Infusion – New Drug Approval – April 23, 2026 - The U.S. Food and Drug Administration approved Otarmeni™ (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Otarmeni™ is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene. <Read More> 

Idvynso™ (doravirine and islatravir) Tablets – New Drug Approval – April 20, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) approved Idvynso™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. <Read More> 

New Label Expansions

Ocrevus® (ocrelizumab) Injection – New Label Expansion – Patient Population Altered: May 8, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older who weigh 55 pounds (25 kg) or more. <Read More> 

Vyvgart® (efgartigimod alfa-fcab) Injection – New Label Expansion – New Indication Approved: May 8, 2026 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the U.S. Food and Drug Administration (FDA) approved a label expansion for Vyvgart® (efgartigimod alfa-fcab) and Vyvgart Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). <Read More> 

Bizengri® (zenocutuzumab-zbco) Injection – New Label Expansion – New Indication Approved: May 8, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for Bizengri® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. <Read More> 

Jakafi™ (ruxolitinib) Tablets - New Label Expansion – New Dosage Form Approved: May 1, 2026 - Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. <Read More> 

Asceniv™ (immune globulin intravenous, human – slra) Injection - New Label Expansion – Patient Population Altered: April 30, 2026 – ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act for Asceniv™. <Read More> 

Auvelity® (dextromethorphan and bupropion) Extended-Release Tablets – New Label Expansion – New Indication Approved: April 30, 2026 – The U.S. Food and Drug Administration approved an expanded use for Auvelity® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity® in 2022 to treat major depressive disorder in adults. <Read More> 

Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate) Inhalation Aerosol – New Label Expansion – Patient Population Altered: April 27, 2026 – AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult and paediatric patients 12 years of age and older. Breztri® is a single-inhaler that combines the efficacy of corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines with a long-acting muscarinic antagonist (LAMA). <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – Labeling Revision Approved: April 24, 2026 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of Caplyta® (lumateperone) for the prevention of relapse in schizophrenia. <Read More> 

Saphnelo® (anifrolumab-fnia) Injection – New Label Expansion – New Dosage Form Approved: April 24, 2026 – AstraZeneca’s Saphnelo® (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo® Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphneloâ led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy. <Read More>

Dupixent® (dupilumab) Injection – New Label Expansion – Patient Population Altered: April 22, 2026 – The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. This expands the previous approval for Dupixent® in adults and adolescents aged 12 years and older with CSU. <Read More> 

Tzield® (teplizumab-mzwv) Injection – New Label Expansion – New Indication Approved: April 20, 2026 – The US Food and Drug Administration (FDA) has approved the supplemental biologic license application for Tzield® (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. <Read More> 

Stelara® (ustekinumab) Injection – New Label Expansion – Patient Population Altered: April 15, 2026 – the U.S. Food and Drug Administration (FDA) approved Stelara® (ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn’s disease (CD). <Read More> 

Filspari® (sparsentan) Tablets – New Label Expansion – New Indication Approved: April 13, 2026 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved Filspari® (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. Filspari® is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease. <Read More> 

Vabysmo® (faricimab-svoa) Intravitreal Injection – New Label Expansion – Labeling Revision Approved: April 9, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Vabysmo® (faricimab-svoa) for the treatment of macular edema due to retinal vein occlusion (RVO) beyond six months. RVO affects over a million Americans and often involves long-term intravitreal therapy to address the chronic nature of the disease. <Read More> 

New Drug Shortage

May 08, 2026

May 07, 2026

May 06, 2026

May 05, 2026

April 29, 2026

Updated Drug Shortage

May 08, 2026

May 07, 2026

May 05, 2026

May 01, 2026

April 30, 2026

New Drug Recall and Safety Alerts

Lactated Ringer’s Injection, 1L, E7500 by B. Braun Medical, Inc. – New Voluntary Recall – April 28, 2026 - B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have particulate matter in solution. <Read More> 

New Generic/Biosimilar Approval and Launch

Langlara™ (insulin glargine-aldy) Injection – New Lantus® Biosimilar Approval – April 29, 2026 - Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma announced that the U.S. Food and Drug Administration (FDA) has approved Langlara™ (insulin glargine-aldy), as a biosimilar to Lantus® (insulin glargine), for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA has determined that Langlara™ is interchangeable with the reference drug, enabling pharmacists to substitute Langlara™ for Lantus® without prescriber intervention in states that permit such substitution. <Read More> 

Clinical and Pharmacy News

Nearly 3,000 Peer-Reviewed Medical Papers Have Fake Citations, a Columbia Nursing AI-Assisted Audit Finds – May 7, 2026 - A new Columbia University School of Nursing AI-assisted audit reveals nearly 3,000 peer-reviewed medical papers have fake citations that do not exist in scientific databases. The results highlight an alarming trend in academic publishing as the use of AI grows. <Read More> 

Pulmonary Embolism Care Gets Major Update – May 2, 2026 - A new clinical practice guideline has outlined a comprehensive, evidence-based framework for evaluating and managing acute pulmonary embolism in adults. The guideline applies to patients aged 18 years and older and spans the full clinical course, from symptom onset through post-acute follow-up. <Read More> 

Americans’ Challenges With Health Care Costs – April 30, 2026 - For many years, KFF polling has found that the high cost of health care is a burden on U.S. families, and that health care costs factor into decisions about insurance coverage and care seeking. These costs also rank as the top financial worry for adults and their families. This data note summarizes recent KFF polling on the public’s experiences with health care costs. <Read More> 

Prescription Drug Affordability: Examining Select Price Drivers – April 27, 2026 - Prescription drug prices heavily influence the public’s perception of health care affordability. A range of market, regulatory, and structural factors shape the timing and strength of competition in prescription drug markets, including the entry and uptake of generics and biosimilars. Even modest delays contribute to higher spending and slower realization of savings for consumers and taxpayers. This brief examines several drivers of prescription drug costs—as well as the market structures that shape their prices, with a focus on the commercial market—to inform policymakers’ discussions around affordability and broader health care cost pressures on consumers. <Read More> 

A Look at Payers' Attitudes Toward Specialty Drug Management  – April 27, 2026 - Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report. The Pharmaceutical Strategies Group (PSG) on Monday released its annual Trends in Specialty Drug Benefits report, which offers a look at how payers are responding to rising costs for these products and striking a balance between cost management and access. <Read More> 

New Study Underscores IRA’s Successes, Opportunities for Future Reforms – April 23, 2026 - A recent JAMA article found two key Inflation Reduction Act (IRA) prescription drug provisions that took effect in 2024—the elimination of coinsurance for catastrophic coverage and the expansion of the Part D low-income subsidy—improved medication adherence among Medicare beneficiaries. <Read More> 

Updated Endometriosis Guidelines: A Step Forward in Ethical Reproductive Healthcare – April 23, 2026 - New clinical guidelines for the diagnosis of endometriosis are welcome news. The guidelines, recently issued by the American College of Obstetricians and Gynecologists (ACOG), recommend that physicians treat patients as “partners and experts about their own bodies,” aligning with reproductive justice imperatives long overdue in the care of people with this common condition. <Read More>  

340B in the News

ASCO Updates 340B Policy Statement to Expand Access, Improve Transparency – May 6, 2026 - For the first time since 2014, the American Society of Clinical Oncology (ASCO) has updated its policy statement on the 340B Drug Pricing Program. The statement was published in JCO Oncology Practice…The new recommendations included in the policy statement are intended to expand practice eligibility, ensure benefit to the intended patients, and address any potential abuses. <Read More>  

The Fight Over 340B: Why a Little-Known Drug Program Matters for Black and Low-Income Patients – May 6, 2026 - Nearly three miles from the halls of power in Washington, Howard University Hospital operates at the intersection of policy and reality—where decisions made on Capitol Hill carry real consequences for patients and their families. Designated by the federal government as a disproportionate share hospital, Howard reflects the very mission behind the federal 340B drug pricing program. For decades, 340B has allowed safety-net providers to stretch limited resources by purchasing discounted medications and reinvesting those savings into patient care. <Read More>  

Read More

Clinical Insights: April 16th, 2026

New Drug/Vaccine Approval

Foundayo™ (orforglipron) Tablets – New Drug Approval – April 1, 2026 - Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. When used alongside a reduced-calorie diet and increased physical activity, Foundayo™ helps individuals lose excess body weight and keep the weight off. Foundayo™ will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers. <Read More>

Awiqli® (insulin icodec-abae) Injection – New Drug Approval – March 26, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers the only once‑weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes. <Read More> 

Kresladi™ (marnetegragene autotemcel) Suspension for Intravenous Infusion – New Drug Approval – March 26, 2026 - The U.S. Food and Drug Administration approved Kresladi™ (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi™ is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant. <Read More> 

Lifyorli™ (relacorilant) Capsules – New Drug Approval – March 25, 2026 - The Food and Drug Administration approved relacorilant (Lifyorli™, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. <Read More> 

Avlayah™ (tividenofusp alfa-eknm) Lyophilized Powder for Injection – New Drug Approval – March 24, 2026 - Denali Therapeutics Inc. (Nasdaq: DNLI) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Avlayah™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. Avlayah™ is an enzyme replacement therapy indicated for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. <Read More> 

Lynavoy™ (linerixibat) Tablets – New Drug Approval – March 17, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Lynavoy™ (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy™, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication. <Read More> 

Icotyde™ (icotrokinra hydrochloride) Tablets – New Drug Approval – March 17, 2026 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Icotyde™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Icotyde™ is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. <Read More> 

Yuviwel® (navepegritide) Lyophilized Powder for Injection - formerly TransCon CNP – New Drug Approval – February 27, 2026 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accelerated Approval Program for Yuviwel® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s). <Read More> 

Desmoda™ (desmopressin acetate) Oral Solution - formerly ET-600 – New Drug Approval – February 25, 2026 - Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for Desmoda™ (desmopressin acetate) Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), as antidiuretic replacement therapy for patients of all ages. <Read More> 

Loargys® (pegzilarginase-nbln) Injection – New Drug Approval – February 23, 2026 - Immedica Pharma announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Loargys® (pegzilarginase-nbln), an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. <Read More> 

Bysanti™ (milsaperidone) Tablets – New Drug Approval – February 20, 2026 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. <Read More> 

New Label Expansions

Eylea HD® (aflibercept) Injection – New Label Expansion – New Dosage Regimen: April 2, 2026 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for Eylea HD® (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the Eylea HD® label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals. <Read More> 

Tecartus® (brexucabtagene autoleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: April 1, 2026 - The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus® (brexucabtagene autoleucel), for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). The full approval now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve. <Read More> 

Spinraza® (nusinersen) Injection – New Label Expansion – New Dosage Regimen: March 27, 2026 - Biogen Inc. (Nasdaq: BIIB) announced that the High Dose Regimen of Spinraza® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of Spinraza® (12 mg), High Dose Spinraza® was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community. <Read More>  

Alyftrek® (deutivacaftor, tezacaftor and vanzacaftor) – New Label Expansion – Labeling Revision Approved: March 27, 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved expanded use of Alyftrek® (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. <Read More> 

neffy® (epinephrine) Nasal Spray – New Label Expansion – Labeling Revision Approved: March 26, 2026 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved updating the neffy® 1 mg (epinephrine nasal spray) prescribing information to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilize neffy® for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirement and be at least four years of age. <Read More>  

Adstiladrin® (nadofaragene firadenovec-vncg) Suspension for Intravesical Use – New Label Expansion – Labeling Revision Approved: March 23, 2026 - Ferring Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Adstiladrin® (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams. <Read More> 

Opdivo® (nivolumab) Injection – New Label Expansion – New Indication Approved: March 20, 2026 - Bristol Myers Squibb (NYSE: BMY) announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union (EU). The U.S. Food and Drug Administration (FDA) granted approval of Opdivo® in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. <Read More> 

Imcivree® (setmelanotide) Injection – New Label Expansion – New Indication Approved: March 19, 2026 - Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for Imcivreeâ (setmelanotide) seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. <Read More> 

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – New Dosage Form Approved: March 19, 2026 - The U.S. Food and Drug Administration approved a new higher dose (7.2 mg) of Wegovy® (semaglutide) injection, called Wegovy® HD, for weight loss and long-term maintenance of weight loss for certain adult patients. The decision was granted just 54 days after filing and represented the fourth approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. <Read More>  

Cosentyx® (secukinumab) Injection – New Label Expansion – Patient Population Altered: March 13, 2026 - Novartis announced that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx® as a meaningful addition to the treatment landscape. <Read More> 

Arexvy™ (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection – New Label Expansion – Patient Population Altered: March 12, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of Arexvy™ (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Arexvy™ was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals. <Read More> 

Wellcovorin™ (leucovorin calcium) Tablets – New Label Expansion – New Indication Approved: March 9, 2026 - The U.S. Food and Drug Administration approved expanded use of Wellcovorin™ (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). <Read More> 

Pylarify™ (piflufolastat F 18) Injection – New Label Expansion – New Formulation Approved: March 6, 2026 - Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced that the U.S. Food and Drug Administration (FDA) has approved Pylarify TruVu™ (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent. Pylarify TruVu™ is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. <Read More>

Sotyktu® (deucravacitinib) Tablets – New Label Expansion – New Indication Approved: March 6, 2026 - Bristol Myers Squibb (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). Sotyktu®, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA. <Read More> 

Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – New Indication Approved: March 5, 2026 - Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli® (teclistamab-cqyv) plus Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. <Read More> 

Palynziq® (pegvaliase-pqpz) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Palynziq® (pegvaliase-pqpz) to include pediatric patients 12 years of age and older with phenylketonuria (PKU). Palynziq® is the only enzyme substitution therapy approved to reduce blood phenylalanine (Phe) concentrations in people with PKU. <Read More>  

Sogroya® (somapacitan-beco) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone. Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya® is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD). <Read More> 

Hernexeos® (zongertinib) Tablets – New Label Expansion – New Indication Approved: February 26, 2026 - The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication is approved under accelerated approval based on objective response rate and duration of response. <Read More> 

Juxtapid® (lomitapide) Capsules – New Label Expansion – Patient Population Altered: February 25, 2026 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Juxtapid® (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older. Juxtapid® is a proven therapy that has been approved in the United States for adult patients with HoFH to be used along with diet and other lipid-lowering treatments, since 2012. <Read More> 

Braftovi® (encorafenib) Capsules – New Label Expansion – New Indication Approved: February 24, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial. <Read More>  

Dupixent® (dupilumab) Injection – New Label Expansion – New Indication Approved: February 23, 2026 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. The FDA evaluated Dupixent® under priority review for the treatment of AFRS, which is reserved for medicines that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This approval expands our approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps. <Read More> 

Elucirem™ (gadopiclenol) Injection – New Label Expansion – Patient Population Altered: February 20, 2026 - Guerbet, a global specialist in contrast media and solutions for medical imaging, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Elucirem™ (gadopiclenol) injection. The new indication includes approval for pediatric patients aged 0-2 years (including term neonates) for its macrocyclic high-relaxivity gadolinium-based contrast agent. <Read More>  

Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – New Indication Approved: February 19, 2026 - AstraZeneca’s Calquence® (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine. <Read More> 

Wakix® (pitolisant) Tablets – New Label Expansion – Patient Population Altered: February 13, 2026 - Harmony Biosciences (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Wakix® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. Wakix® is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy. <Read More> 

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection – New Label Expansion – New Dosage Regimen: February 13, 2026 - Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral Lazcluze® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule. <Read More> 

Enzeevu® (aflibercept-abzv) Injection – New Label Expansion – New Indication Approved: February 12, 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu® (aflibercept-abzv), to include multiple retinal indications. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: February 10, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) and Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens. <Read More>  

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: February 5, 2026 - Kite, a Gilead Company (Nasdaq: GILD), announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).

Ozempic® (semaglutide) Injection and Tablets – New Label Expansion – Labeling Revision Approved: January 30, 2026 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg as the name for oral semaglutide 1.5 mg, 4 mg, and 9 mg. The active ingredient remains the same semaglutide molecule, and the Ozempic® pill is FDA-approved for use in adults with type 2 diabetes to improve blood sugar along with diet and exercise, and to reduce the risk of major adverse cardiovascular events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. <Read More> 

New Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

Updated Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

New Drug Recall and Safety Alerts

Wound Care Gel Products by Blaine Labs, Inc - New Voluntary Recall – April 8, 2026 - Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination. The affected product has been found to contain Lysinibacillus fusiformis, an environmental organism. <Read More> 

Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) by Amneal Pharmaceuticals LLC – New Voluntary Recall – March 24, 2026 - Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. <Read More> 

Webcol™ Large Alcohol Prep Pad by Cardinal Health – New Voluntary Recall – March 19, 2026 - Cardinal Health has issued a voluntary recall for select lots of Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) to the consumer level. The product is being recalled due to microbial contamination identified as Paenibacillus phoenicis. <Read More> 

New Generic/Biosimilar Approval and Launch

Ponlimsi™ (denosumab-adet) Injection – New Prolia® Biosimilar Approval – March 27, 2026 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. The United States (U.S.) Food and Drug Administration (FDA) has approved Ponlimsiä (denosumab-adet) as a biosimilar to Prolia®. <Read More> 

Clinical and Pharmacy News

Questioning the Prescription: Antidepressants and the Medicalization of Childhood – April 10, 2026 – This week Mad in America explores four recently published articles related to antidepressant use in children and adolescents. The first reports that although clinical trials have found little efficacy for the use of fluoxetine (Prozac®) as a treatment for depression in children, clinical guidelines still recommend it. The second finds that persistent antidepressant use is common and rising in Australian children… <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – April 1, 2026 - In the span of a single week in late January and early February 2026, 3 federal actions—by Congress, the Department of Labor (DOL), and the Federal Trade Commission (FTC)—brought transparency efforts to the forefront of drug pricing policy. Whereas recent reforms have centered on prices set by pharmaceutical companies, this new wave of provisions shifts the focus to the role of pharmacy benefit managers (PBMs). <Read More> 

How Hospital Pharmacies Can Access Restrictive Specialty Networks – March 2, 2026 - As payors and pharmacy benefit managers (PBMs) narrow specialty pharmacy networks, health system pharmacies face increasing exclusion from dispensing high-cost therapies to their own patients. For many organizations, accessing these restrictive networks has become both a strategic imperative and an operational challenge. Signature Healthcare, a regional health system in southern Massachusetts, addressed this challenge by partnering with Clearway Health, a specialty pharmacy services organization that originated from Boston Medical Center Health System. Clearway Health now collaborates with hospitals nationwide to improve access to care for patients requiring complex, high-cost medications. <Read More> 

As Rare Disease Drug Approvals Accelerate, Survey Highlights Gaps in Care Coordination – March 2, 2026 - As the pipeline for rare disease therapies continues to expand, new survey data suggest that the healthcare system is not keeping pace with the coordination demands required to deliver those treatments effectively. A national survey commissioned by PANTHERx Rare and conducted by Morning Consult found that patients, caregivers, and healthcare professionals perceive wide gaps in rare disease care delivery, whereas payors view care coordination far more favorably. Among patients and caregivers, 76% rated the current rare disease care system as average, below average, or poor, with 44% describing it as poor. Healthcare professionals were even more critical: 86% rated the system as average or worse, and 50% described it as poor. In contrast, a majority of payors (58%) rated the system as good, revealing what the report describes as a stakeholder disconnect. <Read More> 

Pharmacist Welcomes Bill Restricting Pharmacy Benefit Managers; CVS Projects Mass Closures – February 25, 2026 - Tennessee’s Senate Health and Welfare Committee considered a bill to place restrictions on pharmacy benefit managers (PBMs) on Wednesday. According to the American Medical Association, a pharmacy benefit manager is a middleman in the prescription drug supply chain. They manage prescription drug plan benefits for insurers and employers. PBMs negotiate rebates and discounts, put together networks, and conduct management tasks. Sen. Bobby Harshbarger (R-Kingsport), a pharmacist himself, proposed the bill known as the Fair Rx Act. Christian Tate, a pharmacist at Berry’s Pharmacy in Kingsport, said independent pharmacists just want an equal playing field, and the bill would be a step in the right direction. <Read More> 

Bridging the Gap in Biosimilar Use and Uptake in Inflammatory Conditions – February 24, 2026 - Within the last 5 years, the FDA has approved several key biosimilars for inflammatory conditions such as inflammatory bowel disease and rheumatologic disorders. Infliximab biosimilars entered the market in 2016 as IV infusions only and are billed through the medical benefit. In 2023 and 2025, adalimumab and ustekinumab biosimilars were approved, respectively. Adalimumab has 10 biosimilars, and ustekinumab has 7 on the market. Given that self-administered adalimumab and ustekinumab are billed through the pharmacy benefit, they introduce a new set of challenges and opportunities. This article addresses barriers that arise for the prescribing provider and team, including specialty pharmacists who manage biologic access in collaboration with the clinic, and provides recommendations for future biosimilar utilization. <Read More> 

ACC, AHA Release First-Ever Guideline for Treatment and Management of Acute PE – February 19, 2026 - The new “ACC/AHA Guideline for the Evaluation and Management of Acute Pulmonary Embolism (PE) in Adults” is a de novo document offering comprehensive, evidence‑based recommendations for the evaluation, management and follow‑up of adults with acute PE. Collaborated on and endorsed by an additional eight societies, the new guideline recognizes that management of patients with acute PE "is uniquely multidisciplinary and crosses emergency department, inpatient settings and outpatient clinics." <Read More> 

House Members Push for PBM Changes, Question Trump Drug Plan – February 11, 2026 - Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries. But Guthrie stressed that further changes could be forthcoming. “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.” <Read More> 

340B in the News

AbbVie Challenges 'Outdated' 340B Drug Discount Program Guidance in New Lawsuit – April 9, 2026 - AbbVie is spearheading a new battle in pharma’s long-running fight to reform the federal government’s 340B drug discount program with a lawsuit that challenges the definition of what it means to be a “patient” under the program's framework. AbbVie, a three-decade participant in the 340B system, leveled the suit to “restore integrity” to the drug discount program, the company explained in its 72-page complaint against the Department of Health and Human Services (HHS) and its secretary Robert F. Kennedy Jr., plus the Department of Health Resources and Services Administration (HRSA) and administrator Thomas Engels. <Read More> 

Updates to 340B and What Pharmacists Need to Know – March 26, 2026 - The 340B Drug Pricing Program is a federally mandated drug pricing program created by Congress in 1992 that allows certain health care organizations (called covered entities) to purchase specific outpatient drugs at significantly discounted prices. The core intent is to help these providers “stretch scarce resources” so they can serve low-income and underserved patients, reach more patients, and provide more comprehensive services in their communities. However, despite its original intent, the program faces various challenges in the shape of manufacturer restrictions, legal and regulatory uncertainty, administrative burdens, and compliance risks. As restrictions, litigation, and reimbursement cuts stack up, 340B savings shrink. <Read More> 

Association Between 340B Contract Pharmacy Growth and Payer-Specific Drug Coverage – February 27, 2026 - The 340B Drug Pricing Program entitles participating hospitals and clinics (called covered entities) to purchase outpatient drugs at a substantial discount from manufacturers. Covered entities either distribute 340B drugs at reduced prices to patients or generate a subsidy by charging insured patients market prices for discounted drugs. Drugs purchased through 340B accounted for $66 billion in 2023, with approximately one-fifth of this sum coming from sales through unaffiliated community retail pharmacies, called contract pharmacies. We linked data on contract pharmacy locations to Managed Market Surveyor data to describe the markets in which 340B covered entities locate contract pharmacies. <Read More> 

Report Questions Drug Pricing as Supporters Defend 340B Program – February 19, 2026 - Hospitals and clinics in Michigan participating in a federal drug discount program are marking up medications and shifting costs onto public employee health plans, according to a new analysis. The report from IQVIA, a health data analytics and research company, found that providers participating in the federal 340B Drug Pricing Program are buying medications at steep discounts and billing insurers at much higher rates – increasing costs for both state health plans and taxpayers. <Read More> 

Trump Administration Restarts its Efforts to Pilot 340B Rebates – February 13, 2026 – Only a week after calling it quits on a court-halted pilot program, the Trump administration is already revving the engine on how it could test out a rebate model for the 340B Drug Discount program. The Health Resources and Services Administration (HRSA) released a request for information (RFI) asking stakeholders and the public for input on whether and how such a model should be implemented for 340B, which, for over 30 years, has required drug manufacturers to provide upfront discounts on their products to help subsidize safety-net care. <Read More> 

Following Legal Setbacks, HHS Agrees to Toss 340B Rebate Model Pilot Program – February 6, 2026 - The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals. Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. <Read More> 

Site-of-Care Shift for Physician-Administered Drug Therapies: 2026 Update – January 2026 - Using new Medicare data, this paper updates a prior analysis1 evaluating the site of care for all Medicare Part B drug therapies and finds that previously observed trends are continuing. Specifically, 340B Drug Pricing Program hospital outpatient departments (HOPDs)—including both HOPDs at the hospital itself and off-campus locations—continue to represent a growing share of outpatient drug administrations. This analysis also examines how these trends are reflected in top drugs used to treat breast cancer, rheumatoid arthritis, and multiple myeloma. <Read More> 

Read More

Clinical Insights: April 16th, 2026

New Drug/Vaccine Approval

Foundayo™ (orforglipron) Tablets – New Drug Approval – April 1, 2026 - Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. When used alongside a reduced-calorie diet and increased physical activity, Foundayo™ helps individuals lose excess body weight and keep the weight off. Foundayo™ will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers. <Read More>

Awiqli® (insulin icodec-abae) Injection – New Drug Approval – March 26, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers the only once‑weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes. <Read More> 

Kresladi™ (marnetegragene autotemcel) Suspension for Intravenous Infusion – New Drug Approval – March 26, 2026 - The U.S. Food and Drug Administration approved Kresladi™ (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi™ is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant. <Read More> 

Lifyorli™ (relacorilant) Capsules – New Drug Approval – March 25, 2026 - The Food and Drug Administration approved relacorilant (Lifyorli™, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. <Read More> 

Avlayah™ (tividenofusp alfa-eknm) Lyophilized Powder for Injection – New Drug Approval – March 24, 2026 - Denali Therapeutics Inc. (Nasdaq: DNLI) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Avlayah™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. Avlayah™ is an enzyme replacement therapy indicated for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. <Read More> 

Lynavoy™ (linerixibat) Tablets – New Drug Approval – March 17, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Lynavoy™ (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy™, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication. <Read More> 

Icotyde™ (icotrokinra hydrochloride) Tablets – New Drug Approval – March 17, 2026 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Icotyde™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Icotyde™ is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. <Read More> 

Yuviwel® (navepegritide) Lyophilized Powder for Injection - formerly TransCon CNP – New Drug Approval – February 27, 2026 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accelerated Approval Program for Yuviwel® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s). <Read More> 

Desmoda™ (desmopressin acetate) Oral Solution - formerly ET-600 – New Drug Approval – February 25, 2026 - Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for Desmoda™ (desmopressin acetate) Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), as antidiuretic replacement therapy for patients of all ages. <Read More> 

Loargys® (pegzilarginase-nbln) Injection – New Drug Approval – February 23, 2026 - Immedica Pharma announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Loargys® (pegzilarginase-nbln), an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. <Read More> 

Bysanti™ (milsaperidone) Tablets – New Drug Approval – February 20, 2026 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. <Read More> 

New Label Expansions

Eylea HD® (aflibercept) Injection – New Label Expansion – New Dosage Regimen: April 2, 2026 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for Eylea HD® (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the Eylea HD® label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals. <Read More> 

Tecartus® (brexucabtagene autoleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: April 1, 2026 - The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus® (brexucabtagene autoleucel), for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). The full approval now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve. <Read More> 

Spinraza® (nusinersen) Injection – New Label Expansion – New Dosage Regimen: March 27, 2026 - Biogen Inc. (Nasdaq: BIIB) announced that the High Dose Regimen of Spinraza® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of Spinraza® (12 mg), High Dose Spinraza® was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community. <Read More>  

Alyftrek® (deutivacaftor, tezacaftor and vanzacaftor) – New Label Expansion – Labeling Revision Approved: March 27, 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved expanded use of Alyftrek® (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. <Read More> 

neffy® (epinephrine) Nasal Spray – New Label Expansion – Labeling Revision Approved: March 26, 2026 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved updating the neffy® 1 mg (epinephrine nasal spray) prescribing information to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilize neffy® for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirement and be at least four years of age. <Read More>  

Adstiladrin® (nadofaragene firadenovec-vncg) Suspension for Intravesical Use – New Label Expansion – Labeling Revision Approved: March 23, 2026 - Ferring Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Adstiladrin® (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams. <Read More> 

Opdivo® (nivolumab) Injection – New Label Expansion – New Indication Approved: March 20, 2026 - Bristol Myers Squibb (NYSE: BMY) announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union (EU). The U.S. Food and Drug Administration (FDA) granted approval of Opdivo® in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. <Read More> 

Imcivree® (setmelanotide) Injection – New Label Expansion – New Indication Approved: March 19, 2026 - Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for Imcivreeâ (setmelanotide) seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. <Read More> 

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – New Dosage Form Approved: March 19, 2026 - The U.S. Food and Drug Administration approved a new higher dose (7.2 mg) of Wegovy® (semaglutide) injection, called Wegovy® HD, for weight loss and long-term maintenance of weight loss for certain adult patients. The decision was granted just 54 days after filing and represented the fourth approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. <Read More>  

Cosentyx® (secukinumab) Injection – New Label Expansion – Patient Population Altered: March 13, 2026 - Novartis announced that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx® as a meaningful addition to the treatment landscape. <Read More> 

Arexvy™ (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection – New Label Expansion – Patient Population Altered: March 12, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of Arexvy™ (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Arexvy™ was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals. <Read More> 

Wellcovorin™ (leucovorin calcium) Tablets – New Label Expansion – New Indication Approved: March 9, 2026 - The U.S. Food and Drug Administration approved expanded use of Wellcovorin™ (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). <Read More> 

Pylarify™ (piflufolastat F 18) Injection – New Label Expansion – New Formulation Approved: March 6, 2026 - Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced that the U.S. Food and Drug Administration (FDA) has approved Pylarify TruVu™ (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent. Pylarify TruVu™ is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. <Read More>

Sotyktu® (deucravacitinib) Tablets – New Label Expansion – New Indication Approved: March 6, 2026 - Bristol Myers Squibb (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). Sotyktu®, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA. <Read More> 

Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – New Indication Approved: March 5, 2026 - Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli® (teclistamab-cqyv) plus Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. <Read More> 

Palynziq® (pegvaliase-pqpz) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Palynziq® (pegvaliase-pqpz) to include pediatric patients 12 years of age and older with phenylketonuria (PKU). Palynziq® is the only enzyme substitution therapy approved to reduce blood phenylalanine (Phe) concentrations in people with PKU. <Read More>  

Sogroya® (somapacitan-beco) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone. Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya® is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD). <Read More> 

Hernexeos® (zongertinib) Tablets – New Label Expansion – New Indication Approved: February 26, 2026 - The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication is approved under accelerated approval based on objective response rate and duration of response. <Read More> 

Juxtapid® (lomitapide) Capsules – New Label Expansion – Patient Population Altered: February 25, 2026 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Juxtapid® (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older. Juxtapid® is a proven therapy that has been approved in the United States for adult patients with HoFH to be used along with diet and other lipid-lowering treatments, since 2012. <Read More> 

Braftovi® (encorafenib) Capsules – New Label Expansion – New Indication Approved: February 24, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial. <Read More>  

Dupixent® (dupilumab) Injection – New Label Expansion – New Indication Approved: February 23, 2026 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. The FDA evaluated Dupixent® under priority review for the treatment of AFRS, which is reserved for medicines that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This approval expands our approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps. <Read More> 

Elucirem™ (gadopiclenol) Injection – New Label Expansion – Patient Population Altered: February 20, 2026 - Guerbet, a global specialist in contrast media and solutions for medical imaging, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Elucirem™ (gadopiclenol) injection. The new indication includes approval for pediatric patients aged 0-2 years (including term neonates) for its macrocyclic high-relaxivity gadolinium-based contrast agent. <Read More>  

Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – New Indication Approved: February 19, 2026 - AstraZeneca’s Calquence® (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine. <Read More> 

Wakix® (pitolisant) Tablets – New Label Expansion – Patient Population Altered: February 13, 2026 - Harmony Biosciences (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Wakix® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. Wakix® is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy. <Read More> 

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection – New Label Expansion – New Dosage Regimen: February 13, 2026 - Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral Lazcluze® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule. <Read More> 

Enzeevu® (aflibercept-abzv) Injection – New Label Expansion – New Indication Approved: February 12, 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu® (aflibercept-abzv), to include multiple retinal indications. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: February 10, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) and Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens. <Read More>  

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: February 5, 2026 - Kite, a Gilead Company (Nasdaq: GILD), announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).

Ozempic® (semaglutide) Injection and Tablets – New Label Expansion – Labeling Revision Approved: January 30, 2026 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg as the name for oral semaglutide 1.5 mg, 4 mg, and 9 mg. The active ingredient remains the same semaglutide molecule, and the Ozempic® pill is FDA-approved for use in adults with type 2 diabetes to improve blood sugar along with diet and exercise, and to reduce the risk of major adverse cardiovascular events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. <Read More> 

New Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

Updated Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

New Drug Recall and Safety Alerts

Wound Care Gel Products by Blaine Labs, Inc - New Voluntary Recall – April 8, 2026 - Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination. The affected product has been found to contain Lysinibacillus fusiformis, an environmental organism. <Read More> 

Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) by Amneal Pharmaceuticals LLC – New Voluntary Recall – March 24, 2026 - Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. <Read More> 

Webcol™ Large Alcohol Prep Pad by Cardinal Health – New Voluntary Recall – March 19, 2026 - Cardinal Health has issued a voluntary recall for select lots of Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) to the consumer level. The product is being recalled due to microbial contamination identified as Paenibacillus phoenicis. <Read More> 

New Generic/Biosimilar Approval and Launch

Ponlimsi™ (denosumab-adet) Injection – New Prolia® Biosimilar Approval – March 27, 2026 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. The United States (U.S.) Food and Drug Administration (FDA) has approved Ponlimsiä (denosumab-adet) as a biosimilar to Prolia®. <Read More> 

Clinical and Pharmacy News

Questioning the Prescription: Antidepressants and the Medicalization of Childhood – April 10, 2026 – This week Mad in America explores four recently published articles related to antidepressant use in children and adolescents. The first reports that although clinical trials have found little efficacy for the use of fluoxetine (Prozac®) as a treatment for depression in children, clinical guidelines still recommend it. The second finds that persistent antidepressant use is common and rising in Australian children… <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – April 1, 2026 - In the span of a single week in late January and early February 2026, 3 federal actions—by Congress, the Department of Labor (DOL), and the Federal Trade Commission (FTC)—brought transparency efforts to the forefront of drug pricing policy. Whereas recent reforms have centered on prices set by pharmaceutical companies, this new wave of provisions shifts the focus to the role of pharmacy benefit managers (PBMs). <Read More> 

How Hospital Pharmacies Can Access Restrictive Specialty Networks – March 2, 2026 - As payors and pharmacy benefit managers (PBMs) narrow specialty pharmacy networks, health system pharmacies face increasing exclusion from dispensing high-cost therapies to their own patients. For many organizations, accessing these restrictive networks has become both a strategic imperative and an operational challenge. Signature Healthcare, a regional health system in southern Massachusetts, addressed this challenge by partnering with Clearway Health, a specialty pharmacy services organization that originated from Boston Medical Center Health System. Clearway Health now collaborates with hospitals nationwide to improve access to care for patients requiring complex, high-cost medications. <Read More> 

As Rare Disease Drug Approvals Accelerate, Survey Highlights Gaps in Care Coordination – March 2, 2026 - As the pipeline for rare disease therapies continues to expand, new survey data suggest that the healthcare system is not keeping pace with the coordination demands required to deliver those treatments effectively. A national survey commissioned by PANTHERx Rare and conducted by Morning Consult found that patients, caregivers, and healthcare professionals perceive wide gaps in rare disease care delivery, whereas payors view care coordination far more favorably. Among patients and caregivers, 76% rated the current rare disease care system as average, below average, or poor, with 44% describing it as poor. Healthcare professionals were even more critical: 86% rated the system as average or worse, and 50% described it as poor. In contrast, a majority of payors (58%) rated the system as good, revealing what the report describes as a stakeholder disconnect. <Read More> 

Pharmacist Welcomes Bill Restricting Pharmacy Benefit Managers; CVS Projects Mass Closures – February 25, 2026 - Tennessee’s Senate Health and Welfare Committee considered a bill to place restrictions on pharmacy benefit managers (PBMs) on Wednesday. According to the American Medical Association, a pharmacy benefit manager is a middleman in the prescription drug supply chain. They manage prescription drug plan benefits for insurers and employers. PBMs negotiate rebates and discounts, put together networks, and conduct management tasks. Sen. Bobby Harshbarger (R-Kingsport), a pharmacist himself, proposed the bill known as the Fair Rx Act. Christian Tate, a pharmacist at Berry’s Pharmacy in Kingsport, said independent pharmacists just want an equal playing field, and the bill would be a step in the right direction. <Read More> 

Bridging the Gap in Biosimilar Use and Uptake in Inflammatory Conditions – February 24, 2026 - Within the last 5 years, the FDA has approved several key biosimilars for inflammatory conditions such as inflammatory bowel disease and rheumatologic disorders. Infliximab biosimilars entered the market in 2016 as IV infusions only and are billed through the medical benefit. In 2023 and 2025, adalimumab and ustekinumab biosimilars were approved, respectively. Adalimumab has 10 biosimilars, and ustekinumab has 7 on the market. Given that self-administered adalimumab and ustekinumab are billed through the pharmacy benefit, they introduce a new set of challenges and opportunities. This article addresses barriers that arise for the prescribing provider and team, including specialty pharmacists who manage biologic access in collaboration with the clinic, and provides recommendations for future biosimilar utilization. <Read More> 

ACC, AHA Release First-Ever Guideline for Treatment and Management of Acute PE – February 19, 2026 - The new “ACC/AHA Guideline for the Evaluation and Management of Acute Pulmonary Embolism (PE) in Adults” is a de novo document offering comprehensive, evidence‑based recommendations for the evaluation, management and follow‑up of adults with acute PE. Collaborated on and endorsed by an additional eight societies, the new guideline recognizes that management of patients with acute PE "is uniquely multidisciplinary and crosses emergency department, inpatient settings and outpatient clinics." <Read More> 

House Members Push for PBM Changes, Question Trump Drug Plan – February 11, 2026 - Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries. But Guthrie stressed that further changes could be forthcoming. “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.” <Read More> 

340B in the News

AbbVie Challenges 'Outdated' 340B Drug Discount Program Guidance in New Lawsuit – April 9, 2026 - AbbVie is spearheading a new battle in pharma’s long-running fight to reform the federal government’s 340B drug discount program with a lawsuit that challenges the definition of what it means to be a “patient” under the program's framework. AbbVie, a three-decade participant in the 340B system, leveled the suit to “restore integrity” to the drug discount program, the company explained in its 72-page complaint against the Department of Health and Human Services (HHS) and its secretary Robert F. Kennedy Jr., plus the Department of Health Resources and Services Administration (HRSA) and administrator Thomas Engels. <Read More> 

Updates to 340B and What Pharmacists Need to Know – March 26, 2026 - The 340B Drug Pricing Program is a federally mandated drug pricing program created by Congress in 1992 that allows certain health care organizations (called covered entities) to purchase specific outpatient drugs at significantly discounted prices. The core intent is to help these providers “stretch scarce resources” so they can serve low-income and underserved patients, reach more patients, and provide more comprehensive services in their communities. However, despite its original intent, the program faces various challenges in the shape of manufacturer restrictions, legal and regulatory uncertainty, administrative burdens, and compliance risks. As restrictions, litigation, and reimbursement cuts stack up, 340B savings shrink. <Read More> 

Association Between 340B Contract Pharmacy Growth and Payer-Specific Drug Coverage – February 27, 2026 - The 340B Drug Pricing Program entitles participating hospitals and clinics (called covered entities) to purchase outpatient drugs at a substantial discount from manufacturers. Covered entities either distribute 340B drugs at reduced prices to patients or generate a subsidy by charging insured patients market prices for discounted drugs. Drugs purchased through 340B accounted for $66 billion in 2023, with approximately one-fifth of this sum coming from sales through unaffiliated community retail pharmacies, called contract pharmacies. We linked data on contract pharmacy locations to Managed Market Surveyor data to describe the markets in which 340B covered entities locate contract pharmacies. <Read More> 

Report Questions Drug Pricing as Supporters Defend 340B Program – February 19, 2026 - Hospitals and clinics in Michigan participating in a federal drug discount program are marking up medications and shifting costs onto public employee health plans, according to a new analysis. The report from IQVIA, a health data analytics and research company, found that providers participating in the federal 340B Drug Pricing Program are buying medications at steep discounts and billing insurers at much higher rates – increasing costs for both state health plans and taxpayers. <Read More> 

Trump Administration Restarts its Efforts to Pilot 340B Rebates – February 13, 2026 – Only a week after calling it quits on a court-halted pilot program, the Trump administration is already revving the engine on how it could test out a rebate model for the 340B Drug Discount program. The Health Resources and Services Administration (HRSA) released a request for information (RFI) asking stakeholders and the public for input on whether and how such a model should be implemented for 340B, which, for over 30 years, has required drug manufacturers to provide upfront discounts on their products to help subsidize safety-net care. <Read More> 

Following Legal Setbacks, HHS Agrees to Toss 340B Rebate Model Pilot Program – February 6, 2026 - The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals. Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. <Read More> 

Site-of-Care Shift for Physician-Administered Drug Therapies: 2026 Update – January 2026 - Using new Medicare data, this paper updates a prior analysis1 evaluating the site of care for all Medicare Part B drug therapies and finds that previously observed trends are continuing. Specifically, 340B Drug Pricing Program hospital outpatient departments (HOPDs)—including both HOPDs at the hospital itself and off-campus locations—continue to represent a growing share of outpatient drug administrations. This analysis also examines how these trends are reflected in top drugs used to treat breast cancer, rheumatoid arthritis, and multiple myeloma. <Read More> 

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Ready to get started?

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

Contact Us