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fusion protein
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FDA Extended Its Review of a Marketing Application for Fusion Protein Alprolix
Dec 5, 2013Biogen 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 ...
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European Commission Has Approved Regeneron Pharmaceuticals's Eylea Injection
Sep 2, 2013The European Commission has approved Regeneron Pharmaceuticals's Eylea (aflibercept) injection for the treatment of visual impairment caused by macular edema secondary to central retinal vein occlusion (CRVO). Eylea is a recombinant ...
Tags: fusion protein, Eylea
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Biogen Idec Is Seeking Marketing Approval From The US FDA
Mar 14, 2013Biogen 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
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FDA Has Accepted Biogen Idec's Biologics License Application for The Marketing Approval
Mar 6, 2013The 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
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CSL Behring Received FDA Orphan Drug Designation for CSL Behring rIX-FP
Dec 7, 2012CSL 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
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European Commission Granted Conditional Marketing Authorization for Pfizer's Xalkori
Dec 6, 2012The European Commission has granted conditional marketing authorization for Pfizer’s Xalkori (crizotinib) to treat anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in the European Union (EU). ...
Tags: Xalkori, crizotinib, anaplastic lymphoma kinase, ALK
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Pfizer Has Received Positive Opinion From The Committee
Dec 4, 2012Pfizer has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for crizotinib to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive ...
Tags: Pfizer, CHMP, anaplastic lymphoma kinase
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EC Has Approved Aflibercept Solution for Injection
Nov 29, 2012The European Commission (EC) has approved Bayer HealthCare's EYLEA (aflibercept solution for injection) at a recommended dose of 2 mg for the treatment of wet age-related macular degeneration (wet AMD). Formulated as an iso-osmotic ...
Tags: European Commission, Bayer, Aflibercept Solution, EYLEA
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