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FDA Approves Aimovig as First Calcitonin Gene-Related Peptide (CGRP) Blocker for Migraine Prevention

THOUSAND OAKS, Calif., May 17, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R) …

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FDA Grants Priority Review to Insmed’s ALIS in NTM Lung Disease Caused by MAC

BRIDGEWATER, N.J., May 16, 2018 (GLOBE NEWSWIRE) — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adult …

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Myonexus Receives FDA Rare Pediatric Drug Designation for Investigational Treatment of Limb Girdle Muscular Dystrophy Type 2E

NEW ALBANY, Ohio–(BUSINESS WIRE)–Myonexus Therapeutics, a clinical-stage gene therapy company developing first ever corrective gene therapies for limb girdle muscular dystrophies, and Nationwide Children’s Hospital announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation for the MYO-101 program, an AAV-based gene therapy for …

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FDA Approves Pfizer’s Retacrit, the First Epoetin Alfa Biosimilar for the Treatment of Anemia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S. “As …

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FDA Expands Approval of Gilead’s Truvada to Reduce the Risk of Acquiring HIV-1 in Adolescents

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. The safety and efficacy profile of Truvada …

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With Positive Top-Line Results for PF708 In Osteoporosis Patients, Pfenex Expects to Submit an NDA in Third Quarter 2018

SAN DIEGO, May 14, 2018 /PRNewswire/ — Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to improve protein therapies for unmet patient needs, today announced top-line results from its PF708-301 study, which showed comparable overall profiles between PF708 and Forteo® after 24 weeks of daily …

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FDA Approves Subcutaneous Formulation of Actemra for Use in Active Polyarticular Juvenile Idiopathic Arthritis

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 approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age …

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FDA Approves Novartis’ Gilenya for Pediatric Patients with Relapsing Multiple Sclerosis

Basel, May 11, 2018 – Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients[2]. This …

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FDA Advisory Committee Votes in Favor of Waylivra for Treatment of Familial Chylomicronemia Syndrome

CAMBRIDGE, Mass. and CARLSBAD, Calif., May 10, 2018 (GLOBE NEWSWIRE) — Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that the U.S. Food and Drug Administration’s (FDA) Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of …

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FDA Grants Orphan Drug Designation to SELLAS’ Investigational Multiple Myeloma Drug

NEW YORK, May 09, 2018 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS”), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its novel drug …

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