Latest News

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  FDA approves Inlyta to treat patients with a type of advanced kidney cancer

  0January 27, 2012
  Drug helps keep cancer from progressing The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with...
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  FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

  0January 20, 2012
  Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a...
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  FDA approves Voraxaze to treat patients with toxic methotrexate levels

  0January 17, 2012
  Helps lower high blood levels of the chemotherapy drug The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to...
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  FDA to protect important class of antimicrobial drugs for treating human illness

  0January 4, 2012
  Agency issues order prohibiting certain uses in food-producing animals   The U.S. Food and Drug Administration today issued an order...
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  FDA approves shared system REMS for TIRF products

  0December 29, 2011
  The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal...
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  FDA expands use of HIV drug Isentress to children and adolescents

  0December 21, 2011
  Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the...
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  FDA approves mechanical cardiac assist device for children with heart failure

  0December 16, 2011
    The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with...
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  FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies

  0December 16, 2011
  Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and...
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  FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull

  0December 13, 2011
  Helps to determine if immediate CT scan is needed The U.S. Food and Drug Administration today allowed marketing of the...
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  FDA announces changes to risk strategy requirements for 2 drugs to treat low platelet counts

  0December 6, 2011
  Includes labeling revisions for both drugs The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both...