Baxter International has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of a recombinant antihemophilic porcine sequence factor VIII called 'OBI-1' for the treatment of patients ...
RNAi therapeutics company Alnylam Pharmaceuticals has obtained additional orphan drug designation from US FDA for a RNAi therapeutic, ALN-AT3, to treat hemophilia A. With the additional approval, orphan drug designation for GalNAc ...
Tags: Alnylam, Orphan 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
The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Using the company's ...
Tags: FDA, Idec BLA, hemophilia B
Baxter has submitted a biologics license application (BLA) supplement to the US Food and Drug Administration (FDA) for the approval of its prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, ...
Tags: Baxter, Feiba NF Drug, Medicine
Ipsen and Inspiration Biopharmaceuticals have announced FDA Fast Track status to an intravenous recombinant porcine factor VIII, OBI-1, for acquired hemophilia A therapy. The drug candidate is being studied to treat acquired hemophilia A ...
Tags: FDA, fast track status, drug candidate
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