Biogen Idec announced that the US Food and Drug Administration (FDA) has extended its review of a marketing application for the long-lasting recombinant factor IX Fc fusion protein Alprolix for haemophilia B by three months. The company ...
Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of Rixubis, recombinant factor IX for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B. ...
Tags: Baxter, European Medicines Agency
Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
Biogen Idec is seeking marketing approval from the US Food and Drug Administration (FDA) for recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy to treat hemophilia A. The company has submitted a biologics license application ...
Tags: Biogen Idec, FDA, hemophilia A
CSL Behring has received FDA orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The designation was granted for the treatment and prophylaxis of bleeding episodes in ...
Tags: CSL Behring, rIX-FP, hemophilia B
Baxter International has gained approval for ADVATE [Recombinant Human Coagulation Factor VIII for injection] to treat hemophilia A in China. ADVATE is infused directly into the bloodstream, allowing the body's blood clotting process to ...
Tags: Baxter International, ADVATE, hemophilia A, bleeding episodes
Baxter International has received the US Food and Drug Administration (FDA) approval for its 4000 IU dosage strength of Advate[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. Advate is a full-length recombinant factor ...
Tags: FDA, Baxter hemophilia drug, dosage strength