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FDA Grants Accelerated Approval to Bristol-Myers Squibb’s Opdivo for Treatment of Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.1 Approval …

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FDA Approves Lenvima Capsules for First-Line Treatment of Unresectable Hepatocellular Carcinoma

TOKYO August 17, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib mesylate) for the …

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FDA Approves Regeneron’s Eylea Injection sBLA in Wet Age-Related Macular Degeneration

TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year …

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Wave Life Sciences’ WVE-210201 Granted Orphan Drug and Rare Pediatric Disease Designations from the FDA for Treatment of DMD

CAMBRIDGE, Mass., Aug. 16, 2018 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (NASDAQ: WVE), a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted both orphan drug designation and rare pediatric disease designation for …

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FDA Approves Kalydeco for Treatment of Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO …

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FDA Grants Orphan Drug Designation to Onspira’s Investigational Bronchiolitis Obliterans Therapy

WAYNE, Pa.–(BUSINESS WIRE)–Onspira Therapeutics, a privately-held clinical-stage biopharmaceutical company dedicated to developing therapies to treat rare, life threatening pulmonary diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational product, OSP-101, for the treatment of Bronchiolitis Obliterans (BO). BO is a progressive …

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FDA Grants Breakthrough Therapy Designation to Genentech’s Xolair for Prevention of Severe Allergic Reactions

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair®(omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people …

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Cellectar’s CLR 131 Receives FDA Rare Pediatric Disease Designation for the Treatment of Ewing’s Sarcoma

MADISON, Wis., Aug. 13, 2018 (GLOBE NEWSWIRE) — Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131, …

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FDA Approves Amicus’ Galafold for Treatment of Adults with Fabry Disease

CRANBURY, N.J., Aug. 10, 2018 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Galafold™ (migalastat) 123 mg capsules. Galafold is an oral, precision medicine for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha …

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FDA Approves Alnylam’s RNAi Therapeutic Onpattro for Treatment of Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the United States Food and Drug Administration (FDA) approved ONPATTRO™ (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. ONPATTRO is the …

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