Tag Archives: Biologics License Application

September, 2018

April, 2017

November, 2016

  • 14 November

    FDA Rejects Dynavax’s Hepatitis B Vaccine

    BERKELEY, CA — (Marketwired) — 11/14/16 — Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years …

August, 2016

July, 2016

  • 20 July

    FDA Panel Recommends Approval of Valeant’s Psoriasis Drug

    LAVAL, Quebec, July 19, 2016 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) has voted by a margin of 18 to 0 for the approval of brodalumab injection, 210 …

June, 2016

  • 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 …

January, 2016

  • 27 January

    FDA Accepts Amgen’s BLA for its Humira Biosimilar

    THOUSAND OAKS, Calif., Jan. 25, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). “If approved, we believe ABP 501 could serve as an important additional approved …