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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 Accepts CSL Behring’s Application for New Long-Acting Hemophilia B Product

February 4, 2015

This is an edited version of a press release from CSL Behring. To read the full release, please click here. ____________________  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 […]

EU Gives Hemophilia Sub-Q Injection Orphan Drug Designations

August 7, 2014

Alnylam Pharmaceuticals, Inc. (ALNY), a leading RNAi therapeutics company, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has granted Orphan Drug Designations for ALN-AT3 as an orphan medicinal product for the treatment of hemophilia A and hemophilia B. Alnylam is developing ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin […]


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