Tag Archives: monoclonal antibody

July, 2018

  • 13 July

    Amgen and UCB Resubmit BLA for Evenity to the FDA for the Treatment of Osteoporosis

    THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone …

September, 2017

August, 2017

June, 2017

May, 2017

February, 2016

  • 10 February

    FDA Panel Backs Pfizer and Celltrion’s Proposed Biosimilar Infliximab

    Pfizer Inc. commends today’s recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three. Celltrion’s proposed biosimilar infliximab, to which Pfizer holds exclusive U.S. commercialization rights, is the …