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FDA Accepts Celgene’s Application for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review …

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Protalix and Chiesi to Apply for FDA Accelerated Approval of Pegunigalsidase Alfa for the Treatment of Fabry Disease

CARMIEL, Israel, June 06, 2019 (GLOBE NEWSWIRE) — Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), or Protalix, and Chiesi Farmaceutici S.p.A, an international research-focused healthcare Group, or Chiesi, today announced that, following a series of meetings and correspondence with the U.S. Food and Drug Administration (FDA), they plan to file …

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Alnylam Completes Rolling Submission of Givosiran NDA to the FDA for Treatment of Acute Hepatic Porphyria

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) in development for the treatment …

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FDA Grants Priority Review to Enzyvant’s RVT-802, an Investigational Tissue-Based Regenerative Therapy for Pediatric Congenital Athymia

CAMBRIDGE, Mass. & BASEL, Switzerland–(BUSINESS WIRE)–Enzyvant, a biopharmaceutical company focused on developing and commercializing transformative therapies for patients with rare, often fatal conditions, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for RVT-802, a novel investigational tissue-based regenerative therapy …

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FDA Approves Lilly’s Emgality as the First and Only Treatment for Episodic Cluster Headache that Reduces the Frequency of Attacks

INDIANAPOLIS, June 4, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality®(galcanezumab-gnlm) injection (300 mg) for the treatment of episodic cluster headache in adults.1 Emgality is an innovative therapeutic approach for this neurologic disease and the first and only calcitonin gene-related peptide (CGRP) antibody approved …

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FDA Accepts and Grants Priority Review to Luspatercept BLA in Myelodysplastic Syndromes and Beta-Thalassemia

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s Biologics License Application (BLA) for luspatercept, an investigational erythroid maturation agent, for the treatment of adult patients with very low to intermediate-risk …

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FDA Approves Merck’s Zerbaxa 3g Dose for the Treatment of Adults with Hospital-Acquired Pneumonia

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Merck’s supplemental New Drug Application (sNDA) for the use of ZERBAXA® (ceftolozane and tazobactam) for the treatment of patients 18 years and older with hospital-acquired bacterial …

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FDA Grants Fast Track Designation to SpringWorks’ Investigational Therapy for Treatment of a Severe Form of Neurofibromatosis Type 1

STAMFORD, Conn.–(BUSINESS WIRE)–SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PD-0325901, an investigational, oral, small molecule inhibitor of MEK1 and MEK2, for …

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FDA Grants Priority Review for Daratumumab in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma

Copenhagen, Denmark; May 30, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (U.S. FDA) granted a Priority Review for the supplemental Biologics License Application (sBLA) for the use of daratumumab (DARZALEX®) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for patients …

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Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF). Final data announced today from a 24-week Phase 3 study …

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