Tag Archives: ema

October, 2018

June, 2018

January, 2017

September, 2016

  • 7 September

    Merck Announces FDA’s Priority Review for sBLA for Keytruda

    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 Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small …

April, 2016

March, 2016

  • 2 March

    Baxalta Submits MAA to the EMA for its Hemophilia A Treatment

    BANNOCKBURN, Ill.–(BUSINESS WIRE)– Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of ADYNOVI, an extended circulating half-life recombinant Factor …

February, 2016

January, 2016

  • 13 January

    FDA Grants Priority Review for AbbVie’s Leukemia Candidate

    NORTH CHICAGO, Ill., Jan. 12, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted AbbVie’s New Drug Application (NDA) granting priority review for venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in adults who have received at …