FDA Approves Inluriyo (imlunestrant) for Adults with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer
INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets), an
FDA Grants Accelerated Approval to Forzinity (elamipretide hydrochloride) for the Treatment of Barth Syndrome
NEEDHAM, Mass., Sept. 19, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercializ
FDA Approves Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection Formulation of Keytruda for Use in Solid Tumors
RAHWAY, N.J. -- (BUSINESS WIRE) September 19, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has appr
FDA Approves Enbumyst (bumetanide) Nasal Spray for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease
HENDERSON, Nev.--(BUSINESS WIRE) September 15, 2025 -- Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiova
FDA Approves Inlexzo (gemcitabine intravesical system) for the Treatment of Non-Muscle Invasive Bladder Cancer
September 9, 2025. RARITAN, N.J., September 9, 2025 /PRNewswire/ – Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved Inlexzo (gemcitabine intravesic
FDA Approves Wayrilz (rilzabrutinib) for Immune Thrombocytopenia
Paris, August 29, 2025 -- The US Food and Drug Administration (FDA) has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficien
FDA Approves Dawnzera (donidalorsen) as the First and Only RNA-targeted Prophylactic Treatment for Hereditary Angioedema
CARLSBAD, Calif.--(BUSINESS WIRE) -- Aug. 21, 2025 -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Dawnzera (donidalorsen) f
FDA Approves Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for the Treatment of Fibromyalgia
CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administratio
FDA Approves Papzimeos (zopapogene imadenovec-drba) for the Treatment of Adults with Recurrent Respiratory Papillomatosis
GERMANTOWN, Md, Aug. 15, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patie
FDA Approves Brinsupri (brensocatib) for the Treatment of Non-Cystic Fibrosis Bronchiectasis
BRIDGEWATER, N.J., Aug. 12, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform
FDA Grants Accelerated Approval to Hernexeos (zongertinib) for Previously Treated Patients with HER2-Mutant Advanced NSCLC
Ridgefield, Conn., U.S. and Ingelheim, Germany , August 8, 2025 -- Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase
FDA Grants Accelerated Approval to Modeyso (dordaviprone) for the Treatment of Recurrent H3 K27M-Mutant Diffuse Midline Glioma
DUBLIN, Aug. 6, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso (dordaviprone
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