FDA Approves First Factor X Concentrate for Treatment of a Rare Hereditary Bleeding Disorder

October 21, 2015

Note: The following is an edited version of a press release originally published by the US Food and Drug Administration (FDA). The original release can be read here. The U.S. Food and Drug Administration announced on Tuesday, October 20, 2015, the approval of  Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until […]

FDA To Review CSL Behring’s New Long-Lasting Hemophilia B Product

February 4, 2015

CSL Behring announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Upon FDA approval, rIX-FP will provide hemophilia B patients with a long-acting treatment option with dosing intervals up […]

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