NDA News-CliniExpert

FDA Approves Vyloy (zolbetuximab-clzb) for the Treatment of Advanced Gastric and GEJ Cancer

TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has appro

FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease

NORTH CHICAGO, Ill., Oct. 17, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first

FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors

NEW YORK--(BUSINESS WIRE) October 11, 2024 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis

FDA Approves Itovebi (inavolisib) for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

South San Francisco, CA -- October 10, 2024 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib), in combination wi

FDA Approves Flyrcado (flurpiridaz F 18) Radioactive Diagnostic for Enhanced Diagnosis of Coronary Artery Disease

ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE) September 27, 2024 -- GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado (flurpirid

FDA Approves Otulfi (ustekinumab-aauz), a Biosimilar to Stelara

September 30, 2024 -- Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic c

FDA Approves Cobenfy (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in Adults

PRINCETON, N.J. -- (BUSINESS WIRE) -- 26 September 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospi

FDA Approves Aqneursa (levacetylleucine) for the Treatment of Niemann-Pick Disease Type C

AUSTIN, TX, September 25, 2024 -- IntraBio Inc., a leader in the discovery and development of innovative drugs for rare neurodegenerative diseases, today announced that the U.S. Food and Drug Administ

FDA Approves Miplyffa (arimoclomol) for the Treatment of Niemann-Pick Disease Type C

CELEBRATION, Fla., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage rare disease therapeutics company, today announced that the

FDA Approves Ebglyss (lebrikizumab-lbkz) for the Treatment of Atopic Dermatitis

INDIANAPOLIS, Sept. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibi

FDA Approves Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) Twice-A-Year Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis

South San Francisco, CA -- September 13, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (U.S. FDA) has

FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

South San Francisco, CA -- September 12, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tece