FDA News

FDA Accepts Merck’s BLA for Bezlotoxumab in C. difficile Prevention

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 accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence. The FDA granted Priority …

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FDA Enters Research Collaboration with Commonwealth Informatics

WALTHAM, Mass.–(BUSINESS WIRE)–Commonwealth Informatics, a leading global provider of cloud-based clinical and safety analytics products and services, today announced that it signed a two-year Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA). The focus of the agreement is to enhance the Commonwealth Clinical Data Analytics™ (CCDA) …

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FDA Expands Approval of BMS’ Opdivo in Combination with Yervoy for Certain Melanoma Patients

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.1 This indication is approved under accelerated approval based on progression-free …

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Weather Delays FDA Advisory Committee Meeting of Sarepta’s DMD Candidate

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 20, 2016– Sarepta Therapeutics, Inc.(NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee meeting scheduled for Friday, January 22 has been postponed by the FDA due to an anticipated severe winter snowstorm …

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Amgen’s Kyprolis Receives Expanded Indication by the FDA

PR Newswire, THOUSAND OAKS, Calif. (Jan. 21, 2016) Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or …

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FDA Grants Breakthrough Therapy Designation to AbbVie’s Chronic Lymphocytic Leukemia Drug

NORTH CHICAGO, Ill., Jan. 20, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor …

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Eisai’s Kidney Cancer Drug Receives Priority Review from the FDA

WOODCLIFF LAKE, N.J., Jan. 17, 2016 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for lenvatinib for the potential treatment of patients with unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with …

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FDA Rejects Biomarin’s Duchenne Muscular Dystrophy Drug

SAN RAFAEL, Calif., Jan. 14, 2016 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company’s New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 …

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