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
FDA Approves Vizz (aceclidine ophthalmic solution) for the Treatment of Presbyopia
SAN DIEGO, July 31, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), today announced the US Food and Drug Administration (“FDA”) approved Vizz (aceclidine op
FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria
WARREN, N.J., July 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatme
FDA Approves Anzupgo (delgocitinib) Cream for the Treatment of Chronic Hand Eczema
BALLERUP, Denmark, July 23, 2025 -- LEO Pharma, a global leader in medical dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20
FDA Approves Kirsty (insulin aspart-xjhz), an Interchangeable Biosimilar to NovoLog
BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India: July 15, 2025 -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 53
FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)
CAMBRIDGE, Mass. & SALISBURY, England, July 7, 2025 (BUSINESS WIRE) -- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved E
FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab-gcpt) for Treatment of Relapsed or Refractory Multiple Myeloma
TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for
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