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BLA
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FDA Extended PDUFA Action Date to 16 July 2014 for Investigational Drug Ruconest 50 IU/Kg
Feb 26, 2014Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the ...
Tags: Drug, Pharming Group
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FDA Allergenic Committee Will Meet to Discuss Bla for Ragweed Sublingual AIT Tablet
Dec 30, 2013Denmark-based pharmaceutical company ALK-Abello has announced that the FDA Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) will meet on 28 January 2014 to discuss the biologic license application (BLA) ...
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Vedolizumab Is Under Review for The Treatment of Adults
Dec 27, 2013Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food & Drug Administration (FDA) has extended the Prescription Drug User ...
Tags: Takeda Pharmaceutical Company Limited, Prescription Drug User Fee Act
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Baxter International Submitted a BLA to FDA for Approval of 'OBI-1'
Dec 12, 2013Baxter 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 ...
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Baxter Filed an Amended BLA to Re-Start Review Process to Treat Adult Patients with PI
Dec 5, 2013Baxter International has filed an amended biologics license application (BLA) to the US Food and Drug Administration (FDA) to re-start the review process for approval of HyQvia facilitated subcutaneous infusion to treat adult patients with ...
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EMDAC of The US FDA Voted in Favor of Approval of Vimizim for The Treatment
Nov 26, 2013US-based BioMarin Pharmaceutical has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted in favor of approval of Vimizim for the treatment of Morquio A ...
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Eli Lilly and Company Has Received Priority Review Status From The FDA
Oct 25, 2013Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial ...
Tags: Cancer Drug, FDA Priority
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Novo Nordisk Has Received Biologics Licence Application Approval From FDA
Oct 18, 2013Danish 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
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Genentech Obtained FDA Priority Review Status for GA101 to Treat CLL
Jul 5, 2013Genentech, a member of the Roche Group, has obtained FDA priority review status for Obinutuzumab (GA101) to treat previously untreated chronic lymphocytic leukemia (CLL). The FDA has also accepted the company's biologics license ...
Tags: Genentech, FDA Priority
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Biogen Idec Is Seeking FDA Approval for Plegridy as MS Medication
May 23, 2013Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication. The company submitted a biologics license application (BLA) to the FDA for its pegylated subcutaneous injectable candidate ...
Tags: Biogen IDEC, FDA Approval
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FDA Acceptance of Biologics License Application Sublingual Allergy Immunotherapy Tablet
May 13, 2013Merck, referred to as MSD outside the US and Canada, has announced the FDA acceptance of biologics license application (BLA) of investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet for review. ...
Tags: Merck Biologics, Medicine
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The US FDA Has Accepted Merck's BLA for an Investigational AIT
Mar 28, 2013The US FDA has accepted Merck's biologics license application (BLA) for an investigational allergy immunotherapy tablet (AIT), Timothy grass pollen (Phleum pratense). The application includes safety and efficacy data of the ...
Tags: FDA, Merck Bla, Allergy Immunotherapy Tablet
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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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Baxter Has Submitted a BLA to The US FDA
Feb 28, 2013Baxter 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
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