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  1. CORRECTED-U.S. FDA approves Shire's Vyvanse for binge-eating disorder

    Headlines

    Fri, 30 Jan 2015

    WASHINGTON, Jan 30 (Reuters) - The U.S. Food and Drug Administration on Friday approved Shire Plc's stimulant Vyvanse to treat binge-eating disorder, the first product to be approved for the...

  2. UPDATE 1-U.S. FDA approves Bristol-Myers, J&J HIV pills

    Headlines

    Thu, 29 Jan 2015

    Jan 29 (Reuters) - The U.S. Food and Drug Administration on Thursday approved two fixed-dose HIV pills that combine protease inhibitors - one made by Bristol-Myers Squibb Co and the other by Johnson...

  3. U.S. FDA approves Bristol-Myers' HIV drug

    Headlines

    Thu, 29 Jan 2015

    Jan 29 (Reuters) - The U.S. Food and Drug Administration has approved the sale of Evotaz, a once-daily combination pill to treat HIV made by Bristol-Myers Squibb Co, the company said on Thursday.

  4. UPDATE 2- FDA expands use of Imbruvica to treat rare form of blood cancer

    Headlines

    Thu, 29 Jan 2015

    Jan 29 (Reuters) - The U.S. Food and Drug Administration approved the expanded use of Imbruvica, sold by Johnson & Johnson and Pharmacyclics Inc, to treat Waldenström's macroglobulinemia

  5. FDA expands use of Imbruvica to treat rare form of cancer

    Headlines

    Thu, 29 Jan 2015

    Jan 29 (Reuters) - The U.S. Food and Drug Administration said it cleared an expanded use of Imbruvica to treat Waldenström's macroglobulinemia, a rare form of cancer that begins in the body's immune system.

  6. UPDATE 1-Venaxis' appendicitis test not found equivalent to standard care

    Headlines

    Thu, 29 Jan 2015

    Jan 29 (Reuters) - Venaxis Inc said the U.S. FDA did not find its appendicitis test to be "substantially equivalent" to standard of care, dampening its hopes of marketing the test faster and sending...

  7. Hologic’s Breast-Health Business Fares Well Against New Competition

    Commentary

    Thu, 29 Jan 2015

    franchise. The company has ramped up its marketing campaign to highlight the technology’s U.S. Food and Drug Administration label denoting superiority to 2-D mammography, which is a key differentiator from the equivalency label on

  8. U.S. lawmakers propose bill to create single food safety agency

    Headlines

    Wed, 28 Jan 2015

    WASHINGTON, Jan 28 (Reuters) - U.S. lawmakers proposed a bill on Wednesday that would create a single food safety agency by bringing together the oversight functions of the Food and Drug Administration , U.S. Department of Agriculture and other agencies.

  9. FDA tightens rules for approval of emergency defibrillators

    Headlines

    Wed, 28 Jan 2015

    Jan 28 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it is tightening the requirements for approval of emergency defibrillators following thousands of reports of malfunctioning devices.

  10. Getinge sees end of FDA woes as Q4 profit lags forecast

    Headlines

    Wed, 28 Jan 2015

    Swedish medical technology firm Getinge said on Wednesday it expected to reach a deal soon with the U.S. Food and Drug Administration over quality management, costing it about 500 million Swedish crowns ($61 million) in 2015 as it posted

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