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
FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria
BOSTON, Massachusetts and Cambridge, UK – June 19, 2025 – Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in a
FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection
FOSTER CITY, Calif.--(BUSINESS WIRE) June 18, 2025 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir)—the compa
FDA Approves Andembry (garadacimab-gxii) for Prophylaxis to Prevent Attacks of Hereditary Angioedema
KING OF PRUSSIA, Pa., June 16, 2025 /PRNewswire/ -- Global biotechnology leader CSL today announced the U.S. Food and Drug Administration (FDA) approved Andembry (garadacimab-gxii), the only treatment
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