Latest News

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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 first...
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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 Nplate...
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  FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals

  0December 1, 2011
  Agency provides options for device designs and studies   The U.S. Food and Drug Administration today issued draft guidance designed to help...
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  FDA approves first generic version of cholesterol-lowering drug Lipitor

  0November 30, 2011
  The U.S. Food and Drug Administration today approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).   Ranbaxy...
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  FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep

  0November 23, 2011
  The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia...
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  FDA approves first supplemental test for Chagas disease

  0November 18, 2011
  The U.S. Food and Drug Administration today approved the first test for use as an additional, more specific test on...
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  FDA Commissioner announces Avastin decision

  0November 18, 2011
  Drug not shown to be safe and effective in breast cancer patients FDA Commissioner Margaret A. Hamburg, M.D., said today she...
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  FDA approves Erwinaze to treat a form of leukemia

  0November 18, 2011
  The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL),...
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  FDA Commissioner Removes Breast Cancer Indication from Avastin Label

  0November 18, 2011
  FDA Commissioner Margaret Hamburg is revoking the agency’s accelerated approval of the breast cancer indication for Avastin (bevacizumab), manufactured by Genentech....
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  FDA approves first drug to treat a rare bone marrow disease

  0November 16, 2011
  The U.S. Food and Drug Administration today approved Jakafi (ruxolitinib), the first drug approved to specifically treat patients with the...