Tag Archives: FDA Committee

April, 2018

25 April
FDA Committee Recommends Approval of Baricitinib for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

INDIANAPOLIS, April 23, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis …
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13 October
FDA Committee Unanimously Recommends Approval of Spark’s Gene Therapy for Rare Eye Disease

PHILADELPHIA, Oct. 12, 2017 (GLOBE NEWSWIRE) — Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee has unanimously recommended (16-0) approval of LUXTURNA™ (voretigene neparvovec), an investigational, potential one-time gene therapy, …
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15 June
FDA Panel Scheduled to Review Amgen’s Humira Biosimilar

THOUSAND OAKS, Calif., June 13, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Company’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). “With our heritage in both rheumatology …
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