Tag Archives: Coagulation Factor IX

June, 2017

  • 1 June

    FDA Approves New Novo Nordisk Hemophilia B Treatment

    PLAINSBORO, N.J., May 31, 2017 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B. Hemophilia B is a chronic and inherited bleeding …

March, 2016

  • 7 March

    CSL’s Idelvion Approved for Treatment of Hemophilia B

    KING OF PRUSSIA, Pa. — 04 March 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00 IDELVION, CSL Behring’s long-acting recombinant albumin fusion protein, delivers on the company’s promise to develop and …