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  1. Topamax Gets 6 Month Pediatric Exclusivity Extension [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Jul 25, 2008

    The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures. The

    Also tagged: fda, topamax

  2. Topamax Gets 6 Month Pediatric Exclusivity Extension

    PharmaGazette - Jul 25, 2008

    The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures. The

    Also tagged: fda, topamax

  3. FDA Changes Drug Application Process

    PharmaGazette - Jul 14, 2008

    The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies. Previously the FDA's Center for Drug Evaluation

    Also tagged: fda, cder

  4. FDA Changes Drug Application Process [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Jul 14, 2008

    The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies. Previously the FDA's Center for Drug Evaluation

    Also tagged: fda, cder

  5. GSK Answers FDA on Cervarix

    PharmaGazette - Jun 30, 2008

    GlaxoSmithKline (NYSE: GSK ) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix. Cervarix, a vaccine

    Also tagged: gsk, fda, r, cervical cancer, cervarix

  6. GSK Answers FDA on Cervarix [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Jun 30, 2008

    GlaxoSmithKline (NYSE: GSK ) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix. Cervarix, a vaccine

    Also tagged: gsk, fda, r, cervical cancer, cervarix

  7. FDA Approves Combo Vaccine, Kinrix, for Kids

    PharmaGazette - Jun 25, 2008

    The U.S. Food and Drug Administration has approved GlaxoSmithKline's combination booster vaccine, Kinrix. Kinrix protects children between 4 and 6 years old against diphtheria, pertussis, polio and tetanus and is

    Also tagged: gsk, fda, infanrix, kinrix, pediarix

  8. FDA Approves Combo Vaccine, Kinrix, for Kids [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Jun 25, 2008

    The U.S. Food and Drug Administration has approved GlaxoSmithKline's combination booster vaccine, Kinrix. Kinrix protects children between 4 and 6 years old against diphtheria, pertussis, polio and tetanus and is

    Also tagged: gsk, fda, infanrix, kinrix, pediarix

  9. FDA Delays Prasugrel Approval 3 Months

    PharmaGazette - Jun 25, 2008

    Eli Lilly & Co and Daiichi Sankyo announced the U.S. Food and Drug Administration had extended the period of review by three months for their anti-clotting drug, Prasugrel. Prasugrel received priority review

    Also tagged: fda, eli lilly, plavix, parasugrel, daiichi

  10. FDA Delays Prasugrel Approval 3 Months [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Jun 25, 2008

    Eli Lilly & Co and Daiichi Sankyo announced the U.S. Food and Drug Administration had extended the period of review by three months for their anti-clotting drug, Prasugrel. Prasugrel received priority review

    Also tagged: fda, eli lilly, plavix, parasugrel, daiichi

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