BLA

Results: 1118



#Item
891Biotechnology / Dendreon / Center for Biologics Evaluation and Research / ICAM-1 / BLA / Pharmacovigilance / Food and Drug Administration / Biologic / Pharmacology / Pharmaceutical sciences / Medicine

DEPARTMENT OF HEALTH AND HUMAN SERVICES ______________________________________________________________________________ TELECONFERENCE MEMORANDUM Date\Time:

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Source URL: www.fda.gov

Language: English
892Heparins / General anesthetics / Etomidate / Imidazoles / Janssen Pharmaceutica / Methadone / Netilmicin / Treprostinil / Chemistry / Organic chemistry / Amines

BLA[removed]GTC Biotherapeutics

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Source URL: www.fda.gov

Language: English
893Validity / Biotechnology / Clinical research / Quality / Validation / Cell therapy / HTML element / Form FDA 483 / Fibroblast / Biology / Cell biology / Pharmaceutical industry

CMC REVIEW BLA[removed]Division of Cell and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies Reviewed by:

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Source URL: www.fda.gov

Language: English
894Validity / Science / Dendreon / Cancer vaccines / Validation / Apheresis / Cell therapy / Prostate cancer / Verification and validation / Biology / Medicine / Pharmaceutical industry

CMC REVIEW BLA[removed]Sipuleucel-T (Provenge®) Dendreon Corporation

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Source URL: www.fda.gov

Language: English
895Coagulation system / Anticoagulants / ATryn / Genetic engineering / Goats / Antithrombin III deficiency / Deep vein thrombosis / Antithrombin / Pulmonary embolism / Hematology / Blood / Health

Mid Cycle review of the BLA (STN[removed])

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Source URL: www.fda.gov

Language: English
896Science / Center for Drug Evaluation and Research / Center for Devices and Radiological Health / Clinical trial / Food and Drug Administration / Research / Health

The Isolagen BLA was received on March 6 and has been assigned STN[removed]

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Source URL: www.fda.gov

Language: English
897

BLA Mid Cycle Meeting - Provenge, February 27, 2007

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Source URL: www.fda.gov

    898Relaxin / Pharmaceutical industry / Biology / Anatomy / Novartis / Heart failure

    BLA[removed]serelaxin (Novartis)

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    Source URL: www.fda.gov

    Language: English
    899Redaction / Validation / Clinical research / Pharmaceutical industry / Editing

    Dendreon – sipuleucel-T (Provenge) - BLA STN[removed]

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    Source URL: www.fda.gov

    Language: English
    900

    Re-evaluation of proposed proprietary name Provenge - BLA STN[removed], Provenge,

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    Source URL: www.fda.gov

      UPDATE