In the News

Here's a catalog of all the Latest Brand Drug Approvals from the FDA happening now.
Generic FDA Drug Updates

FDA Approves Rextovy (naloxone hydrochloride) Nasal Spray for Over-the-Counter Use

June 16, 2026 -- The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose...
June 20, 2026 1:06 AM

FDA Approves Utebzi (tebipenem pivoxil) for Adults with Complicated Urinary Tract Infections

GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including...
June 16, 2026 10:06 PM

Sanofi’s Tzield Approved in the US as the First Disease-Modifying Therapy for Patients Recently Diagnosed with Stage 3 Type 1 Diabetes

Paris, June 13, 2026. The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with...
June 13, 2026 1:06 PM

FDA Approves Lilly's Ebglyss (lebrikizumab-lbkz) for One Maintenance Dose Every Eight Weeks in Patients with Moderate-to-Severe Atopic Dermatitis

INDIANAPOLIS, June 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of Ebglyss...
June 8, 2026 7:06 PM

U.S. FDA Approves Pfizer’s Hympavzi for the Treatment of Two Additional Hemophilia A or B Patient Populations with Significant Medical Need

NEW YORK--(BUSINESS WIRE) June 08, 2026 -- Pfizer Inc. (NYSE: PFE) today 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...
June 8, 2026 5:06 PM

FDA Approves Label Expansion, Cementing Tremfya as the Only IL‑23 Inhibitor Proven to Help Stop Further Joint Damage

HORSHAM, PA – (May 28, 2026) – Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the Tremfya...
May 27, 2026 9:05 PM

FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

OSAKA, Japan, June 1, 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...
June 1, 2026 4:06 PM

FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections

MUMBAI & SHORT HILLS, NEW JERSEY May 30, 2026 – Wockhardt today 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...
May 30, 2026 5:05 PM

MannKind Announces FDA Approval of Afrezza, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for...
May 29, 2026 3:05 PM

Imfinzi Approved in the US in First and Only Immunotherapy Combination for Patients with BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer

May 28, 2026 -- AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naïve, high-risk...
May 28, 2026 3:05 PM

FDA Approves Decnupaz (pivekimab sunirine-pvzy) for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

NORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and...
May 27, 2026 1:05 PM

FDA Approves Use of Linzess (linaclotide) in Pediatric Patients Two Years of Age and Older with Functional Constipation (FC)

BOSTON--(BUSINESS WIRE) May 27, 2026 -- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced...
May 27, 2026 2:05 PM

FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of Acne

Zug, Switzerland – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin Epiduo Acne Gel (Adapalene 0.1% and...
May 24, 2026 2:05 PM

Datroway Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates

Tokyo – (May 22, 2026) – Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/NYSE: AZN) Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic...
May 22, 2026 3:05 PM

FDA Grants Accelerated Approval to Hepcludex (bulevirtide-gmod) Treatment for Chronic Hepatitis Delta Virus (HDV)

FOSTER CITY, Calif.--(BUSINESS WIRE) May 22, 2026 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment...
May 22, 2026 3:05 PM

FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

South San Francisco, CA -- May 15, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza&reg...
May 15, 2026 4:05 PM

FDA Approves New Dosing Option for Crysvita (burosumab-twza) in Adults With XLH

Princeton, N.J., May 14, 2026 – Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd., today announced the U.S. Food and Drug Administration (FDA) has approved a dosing update to the Crysvita (burosumab-twza) Prescribing...
May 13, 2026 6:05 PM

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

Cary, N.C., May 18, 2026—Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved Trimbow® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or...
May 18, 2026 12:05 AM

Fasenra Approved in US for Hypereosinophilic Syndrome

14 May 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...
May 13, 2026 11:05 PM

Enhertu Approved in the US for Two New Indications for Patients with HER2 Positive Early Breast Cancer

Tokyo – (May 15, 2026) – Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved by the U.S. Food and Drug Administration (FDA) for two new breast cancer indications in the neoadjuvant and adjuvant settings of patients with HER2...
May 15, 2026 4:05 PM

FDA Approves Immgolis Intri (golimumab-sldi), an Interchangeable Biosimilar to Simponi Aria (golimumab)

RALEIGH, N.C., May 18, 2026 /PRNewswire/ — Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS)...
May 17, 2026 8:05 PM

FDA Approves Immgolis (golimumab-sldi), an Interchangeable Biosimilar to Simponi

RALEIGH, N.C., May 18, 2026 /PRNewswire/ — Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS)...
May 15, 2026 4:05 PM

FDA Approves Baxfendy (baxdrostat) as the First Aldosterone Synthase Inhibitor Treatment for Adults with Hypertension

May 18, 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...
May 18, 2026 4:05 PM

FDA Approves Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi) as the First Interchangeable Biosimilars to Simponi and Simponi Aria

May 15, 2026 -- FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi (golimumab) and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria (golimumab)...
May 15, 2026 4:05 PM

FDA Approves Inqovi in Combination with Venetoclax, the First All-Oral Combination Treatment for Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Chemotherapy

PRINCETON, N.J. and TOKYO — May 13, 2026 -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved Inqovi (decitabine and cedazuridine) plus venetoclax as a...
May 13, 2026 3:05 PM

FDA Grants Accelerated Approval to Beqalzi (sonrotoclax) for Relapsed or Refractory Mantle Cell Lymphoma

SAN CARLOS, Calif.--(BUSINESS WIRE) May 13, 2026 -- BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted...
May 13, 2026 3:05 PM

argenx Announces U.S. FDA Approval Expanding Vyvgart and Vyvgart Hytrulo for Use in All Adult Patients Living with gMG

Amsterdam, the Netherlands – May 8, 2026 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the U.S. Food and Drug...
May 8, 2026 4:05 PM

FDA Approves Ocrevus for Relapsing-Remitting Multiple Sclerosis In Pediatric Patients 10 Years of Age And Older

South San Francisco, CA - May 8th, 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...
May 8, 2026 4:05 PM

Partner Therapeutics Announces Receipt of FDA Commissioner’s National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma

LEXINGTON, Mass. – May 06, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority...
May 6, 2026 3:05 PM

ADMA Biologics Announces FDA Approval to Expand the Label for Asceniv to Include Pediatric Immune Compromised Patients Two Years of Age and Older

RAMSEY, N.J. and BOCA RATON, Fla., May 04, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing...
May 4, 2026 3:05 PM

FDA Approves Langlara (insulin glargine-aldy) an Interchangeable Biosimilar to Lantus

PHILADELPHIA - May 4, 2026 - Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved Langlara (insulin glargine-aldy), as a...
May 4, 2026 3:05 PM

Incyte Announces FDA Approval of Jakafi XR (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease

WILMINGTON, Del.--(BUSINESS WIRE)--May 1, 2026-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with...
April 30, 2026 8:05 PM

FDA Approves Veppanu (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

NEW HAVEN, Conn., May 01, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today 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...
April 30, 2026 8:05 PM

Axsome Therapeutics Announces FDA Approval of Auvelity (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer’s Disease

NEW YORK, April 30, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug...
April 30, 2026 3:04 PM

Breztri Approved in the US for Asthma as First and Only Triple Therapy for Patients 12 Years of Age and Older

April 28, 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...
April 28, 2026 2:04 PM

FDA Approves Caplyta (lumateperone) sNDA with Robust New Data Supporting Reduced Risk of Relapse in Schizophrenia

TITUSVILLE, N.J. (APRIL 27, 2026) – Johnson & Johnson announced today 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...
April 27, 2026 2:04 PM

Saphnelo Approved in the US for Subcutaneous Self-Administration as a New Autoinjector for the Treatment of Systemic Lupus Erythematosus

27 April 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...
April 27, 2026 2:04 PM

FDA Approves Updated Vabysmo Label to Extend Treatment for Macular Edema Following Retinal Vein Occlusion (RVO) Beyond Six Months

South San Francisco, CA — April 9th, 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...
April 8, 2026 8:04 PM

Sanofi's Tzield Approved in the U.S. to Delay the Onset of Stage 3 Type 1 Diabetes in Young Children

Paris, April 22, 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...
April 22, 2026 5:04 PM

Sanofi and Regeneron’s Dupixent Approved in the U.S. as the First Biologic Medicine for Young Children with Uncontrolled Chronic Spontaneous Urticaria

Paris and Tarrytown, NY, 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...
April 22, 2026 5:04 PM

FDA Grants Accelerated Approval for Otarmeni (lunsotogene parvec-cwha) Gene Therapy for Genetic Hearing Loss

TARRYTOWN, N.Y., April 23, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), the first...
April 23, 2026 5:04 PM

FDA Approves Idvynso (doravirine and islatravir) for the Treatment of HIV-1 Infection in Adults

RAHWAY, N.J.--(BUSINESS WIRE) April 21, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved Idvynso, a new, two-drug single-tablet regimen of...
April 21, 2026 2:04 PM

Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the First and Only Approved Medicine for Focal Segmental Glomerulosclerosis (FSGS)

SAN DIEGO--(BUSINESS WIRE) April 13, 2026 -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved Filspari (sparsentan) to reduce proteinuria in adult and pediatric patients aged...
April 12, 2026 11:04 PM

Cumberland Pharmaceuticals Announces Expanded Indication for Caldolor (ibuprofen) Injection

NASHVILLE, Tenn., April 16, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication...
April 15, 2026 10:04 PM

Eylea HD (aflibercept) Approved by FDA as First and Only Injectable Anti-VEGF with Dosing Intervals Up to 5 Months for Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME)

TARRYTOWN, N.Y., April 02, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for Eylea HD® (aflibercept) up to...
April 2, 2026 4:04 PM

U.S. FDA Grants Full Approval of Kite’s Tecartus for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

SANTA MONICA, Calif. – April 2, 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...
April 2, 2026 5:04 PM

Vertex Announces US FDA Approval for Label Extensions of Alyftrek and Trikafta, Expanding Availability of These Medicines to ~95% of All People With CF in the United States

BOSTON--(BUSINESS WIRE)--Apr. 1, 2026-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of...
March 31, 2026 7:04 PM

FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions

INDIANAPOLIS, April 1, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical...
April 1, 2026 12:04 PM

FDA Approves Ponlimsi (denosumab-adet), a Biosimilar to Prolia

TEL AVIV, Israel and PARSIPPANY, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Ponlimsi...
March 31, 2026 5:03 PM

FDA Approves New High Dose Regimen of Spinraza (nusinersen) for Spinal Muscular Atrophy

CAMBRIDGE, Mass., March 30, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today 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...
March 30, 2026 1:03 PM

ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy 1 mg (epinephrine nasal spray) Label

SAN DIEGO, March 27, 2026 (GLOBE NEWSWIRE) -- 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...
March 27, 2026 4:03 PM

FDA Approves Awiqli (insulin icodec-abae) as the First and Only Once-Weekly Basal Insulin Treatment for Adults with Type 2 Diabetes

PLAINSBORO, N.J., March 26, 2026 /PRNewswire/ -- Novo Nordisk today 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...
March 26, 2026 3:03 PM

FDA Grants Accelerated Approval for Kresladi for the Treatment of Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I)

CRANBURY, N.J.--(BUSINESS WIRE)--Mar. 27, 2026-- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced...
March 27, 2026 1:03 PM

FDA Approves Lifyorli (relacorilant) Plus Nab-Paclitaxel for the Treatment of Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar. 25, 2026-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and...
March 25, 2026 3:03 PM

FDA Grants Accelerated Approval for Avlayah (tividenofusp alfa-eknm) for the Treatment of Hunter Syndrome (MPS II)

SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Avlayah™ (tividenofusp alfa-eknm), the...
March 25, 2026 3:03 PM

U.S. FDA Approves Label Update to Accelerate Thaw Time for Adstiladrin (nadofaragene firadenovec-vncg)

Parsippany, NJ, March 24, 2026 – Ferring Pharmaceuticals today 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...
March 24, 2026 5:03 PM

Bristol Myers Squibb Transforms the Classical Hodgkin Lymphoma Treatment Paradigm with Expanded U.S. Approval for Opdivo (nivolumab)

PRINCETON, N.J.--(BUSINESS WIRE) March 20, 2026 -- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union...
March 20, 2026 2:03 PM

Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Patients with Acquired Hypothalamic Obesity

BOSTON, March 19, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that...
March 18, 2026 11:03 PM

FDA Approves Lynavoy (linerixibat) for Cholestatic Pruritus in Patients with Primary Biliary Cholangitis

London, UK 19 March 2026 -- GSK plc (LSE/NYSE: GSK) today 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...
March 19, 2026 1:03 PM

FDA Approves Novo Nordisk’s New Wegovy HD Injection, Delivering the Highest Weight Loss to Date for a Wegovy Injection

PLAINSBORO, N.J., March 19, 2026 /PRNewswire/ -- Novo Nordisk today announced US Food and Drug Administration (FDA) approval of a new higher dose of Wegovy, Wegovy HD (semaglutide) injection 7.2 mg, which demonstrated substantial weight loss in...
March 19, 2026 1:03 PM

FDA Approves Icotyde (icotrokinra) for the Treatment of Plaque Psoriasis

SPRING HOUSE, Pa. (March 18, 2026) – Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Icotyde (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of...
March 18, 2026 12:03 PM

GSK’s RSV Vaccine, Arexvy, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased Risk

13 March 2026 London, UK -- GSK plc (LSE/NYSE: GSK) today 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...
March 13, 2026 3:03 PM

Novartis Cosentyx Receives FDA Approval for Pediatric Patients Aged 12+ with Moderate to Severe Hidradenitis Suppurativa

Basel, March 13, 2026 – Novartis announced today 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)...
March 13, 2026 3:03 PM

FDA Approves Expanded Use of Wellcovorin (leucovorin calcium) for Patients with Cerebral Folate Transport Deficiency

March 10, 2026 -- The U.S. Food and Drug Administration today 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...
March 10, 2026 1:03 PM

Lantheus Announces FDA Approval of Pylarify TruVu (piflufolastat F 18) Injection

BEDFORD, Mass., March 06, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better...
March 5, 2026 8:03 PM

U.S. FDA Approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis

PRINCETON, N.J.--(BUSINESS WIRE) March 6, 2026 -- Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis...
March 6, 2026 1:03 PM

Johnson & Johnson Announces U.S. FDA Approval of Tecvayli plus Darzalex Faspro for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line

HORSHAM, Pa. (March 5, 2026) – Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) plus Darzalex Faspro...
March 5, 2026 1:03 PM

New Indication in Pediatric Patients, Including Term Neonates for Guerbet’s Half-Dose GBCA, Elucirem (gadopiclenol) Injection

Princeton, NJ, 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&trade...
February 20, 2026 3:02 PM

FDA Approves Vueway (gadopiclenol) Solution for Injection, Intravenous Use, for Use in Neonates and Infants

PRINCETON, N.J., Feb. 23, 2026 /PRNewswire/ -- Bracco, a global leader in diagnostic imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the current Vueway (gadopiclenol) solution for injection...
February 23, 2026 2:02 PM

Chiesi Global Rare Diseases Announces FDA Approval of Juxtapid (lomitapide) Capsules for Pediatric Use in Homozygous Familial Hypercholesterolemia (HoFH)

BOSTON, March 03, 2026 (GLOBE NEWSWIRE) -- 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 today that the U.S. Food and Drug...
March 3, 2026 3:03 PM

U.S. Food and Drug Administration Approves BioMarin’s Palynziq (pegvaliase-pqpz) for Adolescents 12 Years of Age and Older with Phenylketonuria (PKU)

SAN RAFAEL, Calif., Feb. 27, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Palynziq...
March 1, 2026 6:03 PM

FDA Approves Novo Nordisk's Sogroya as the First and Only Once-Weekly, Long-Acting Growth Hormone for Three Additional Pediatric Indications

PLAINSBORO, N.J., Feb. 27, 2026 /PRNewswire/ -- Novo Nordisk today 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...
February 27, 2026 5:02 PM

FDA Grants Accelerated Approval to Yuviwel (navepegritide) for Children with Achondroplasia

COPENHAGEN, Denmark, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accelerated Approval Program for Yuviwel...
February 27, 2026 2:02 PM

FDA Approves Desmoda (desmopressin acetate) Oral Solution for Central Diabetes Insipidus

DEER PARK, Ill., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare...
February 24, 2026 11:02 PM

FDA Approves Hernexeos, the First Targeted Therapy for Adults with HER2-Mutant Advanced NSCLC as an Initial Treatment Option

Ridgefield, Conn. and Ingelheim, Germany, 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...
February 25, 2026 10:02 PM

U.S. FDA Grants Full Approval to Pfizer’s Braftovi Combination Regimen in First-Line Metastatic Colorectal Cancer

NEW YORK--(BUSINESS WIRE) February 24, 2026 -- Pfizer Inc. (NYSE: PFE) today 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...
February 24, 2026 4:02 PM

FDA Grants Accelerated Approval to Loargys (pegzilarginase-nbln) for the treatment of Hyperargininemia in Patients with Arginase 1 Deficiency

STOCKHOLM, Sweden, February 23, 2026 - Immedica Pharma today 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...
February 23, 2026 5:02 PM

Dupixent (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS)

TARRYTOWN, N.Y. and PARIS, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and...
February 24, 2026 3:02 PM

Zepbound (tirzepatide) Now Available in Multi-Dose KwikPen

INDIANAPOLIS, Feb. 23, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved a label expansion for Zepbound® (tirzepatide) to include the four-dose single-patient use...
February 23, 2026 2:02 PM

FDA Grants Accelerated Approval to Loargys (pegzilarginase-nbln) for the treatment of Hyperargininemia in Patients 2 Years and Older with Arginase 1 Deficiency (ARG1-D)

STOCKHOLM, Sweden, February 23, 2026 - Immedica Pharma today 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...
February 23, 2026 5:02 PM

Calquence Plus Venetoclax Approved in the US as First All-Oral, Fixed-Duration Combination for Patients with Chronic Lymphocytic Leukemia in the 1st-Line Setting

20 February 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)...
February 20, 2026 2:02 PM

FDA Approves Bysanti (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia

February 20, 2026 WASHINGTON, Feb. 20, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti (milsaperidone) tablets, a first line therapy for the acute...
February 22, 2026 4:02 PM

FDA Approves Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis

East Windsor, NJ - February 13, 2026 - Acrotech Biopharma Inc., a bio-pharmaceutical company focused on developing and commercializing innovative propriety medications, in collaboration with Otsuka Pharmaceutical Co., Ltd., today announces that the...
February 13, 2026 5:02 PM

Sandoz Receives US FDA Approval to Expand Enzeevu (aflibercept-abzv) Label for Multiple Retinal Indications

Basel, February 18, 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu (aflibercept-abzv), to include...
February 18, 2026 1:02 PM

Harmony Biosciences Receives U.S. Food and Drug Administration Approval for Wakix (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Feb. 17, 2026-- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Wakix® (pitolisant) tablets...
February 16, 2026 7:02 PM

FDA Approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the Only EGFR-Targeted Therapy that can be Administered Once a Month

HORSHAM, P.A. (February 17, 2026) – Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for Rybrevant Faspro (amivantamab and...
February 17, 2026 1:02 PM

Keytruda and Keytruda Qlex, Plus Paclitaxel ± Bevacizumab, Approved for Certain Adults with PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma

RAHWAY, N.J.--(BUSINESS WIRE) February 11, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) and Keytruda Qlex...
February 11, 2026 12:02 PM

FDA Approves Label Update for Kite’s Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma

SANTA MONICA, Calif.--(BUSINESS WIRE) February 6, 2026 -- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta (axicabtagene ciloleucel) prescribing information...
February 6, 2026 1:02 PM

FDA Approves Vybrique (sildenafil) Oral Film to Treat Men with Erectile Dysfunction

Parsippany, NJ, February 5, 2026 – IBSA USA, the U.S. subsidiary of the Swiss pharmaceutical company IBSA, announced today that the Food and Drug Administration (FDA) has approved Vybrique, the first sildenafil oral film available to treat men...
February 5, 2026 4:02 PM

Novo Nordisk Introduces Ozempic Pill; Available in the US Q2 2026

PLAINSBORO, N.J., February 4, 2026 – Novo Nordisk today 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...
February 4, 2026 1:02 PM

FDA Approves Yuvezzi (carbachol and brimonidine tartrate) Ophthalmic Solution to Treat Presbyopia

LONDON, U.K. and SEATTLE, Wash., January 28, 2026 – Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the aging eye, today announced that the U.S. Food...
January 28, 2026 2:01 PM

MannKind Announces FDA Approval of Updated Afrezza Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for...
January 26, 2026 12:01 PM

Darzalex Faspro-Based Quadruplet Regimen Approved for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible

HORSHAM, Pa., January 27, 2026 – Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and...
January 27, 2026 3:01 PM

Organon Announces US FDA Approval of Supplemental New Drug Application Extending Duration of Use of Nexplanon (etonogestrel implant) for Up to Five Years

JERSEY CITY, N.J.--(BUSINESS WIRE) January 16, 2026 -- Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration...
January 16, 2026 2:01 PM

FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura in Pediatric Patients 12 Years and Older

On Dec. 23, 2025, the U.S. Food and Drug Administration approved Cablivi (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange...
December 23, 2025 3:12 PM

FDA Approves Oziltus (denosumab-mobz), a Biosimilar to Xgeva

BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma...
December 21, 2025 9:12 PM

FDA Approves Boncresa (denosumab-mobz), a Biosimilar to Prolia

BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today...
December 21, 2025 9:12 PM

FDA Approves Nereus (tradipitant) for the Prevention of Motion Sickness

WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Nereus (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the...
December 30, 2025 3:12 PM

FDA Approves Nufymco (ranibizumab-leyk), an Interchangeable Biosimilar to Lucentis

Planegg-Martinsried, Germany - December 23, 2025 – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco®1...
December 22, 2025 9:12 PM

FDA Approves Yartemlea (narsoplimab-wuug) for the Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy

SEATTLE--(BUSINESS WIRE)--Dec. 24, 2025-- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated...
December 24, 2025 5:12 PM
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