NDA News-CliniExpert

FDA Approves Clotic (clotrimazole otic solution), First Treatment with Clinical Evidence for Fungal Ear Infections

September 2025: Madrid, Spain, 26 September 2025 -- Laboratorios Salvat, S.A. ("Salvat") announced today that the U.S. Food and Drug Administration (FDA) has approved Clotic (clotrimazole ot

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