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  1. FDA approves Eliquis label expansion

    Headlines

    Thu, 21 Aug 2014

    The FDA clears Eliquis ( apixaban ) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the reduction

  2. UPDATE 1- FDA approves use of Eliquis to treat leg, lung clots

    Headlines

    Thu, 21 Aug 2014

    Aug 21 (Reuters) - Bristol-Myers Squibb Co and Pfizer Inc on Thursday said U.S. regulators have approved an expanded use for their Eliquis blood clot preventer, to treat blood clots in the legs and...

  3. Tekmira Pharmaceuticals: What Does The 'Animal Rule' Mean For Their Ebola Drug Development?

    Headlines

    Thu, 21 Aug 2014

    Ebola drug, TKM-Ebola, was being tested on animals under the FDA ’s “Animal Rule”. While this is an accurate statement, a ..... Government Agency Efficacy testing conducted on animals under FDA ’s Animal Rule regulatory guideline Phase 1 safety trial on

  4. FDA OKs use of Eliquis to treat leg, lung clots

    Headlines

    Thu, 21 Aug 2014

    Aug 21 (Reuters) - Bristol-Myers Squibb Co and Pfizer Inc on Thursday said U.S. regulators have approved an expanded use for their Eliquis blood clot preventer, to treat dangerous blood clots in the legs and lungs.

  5. Canada clears next gen imaging technology for Visius

    Headlines

    Thu, 21 Aug 2014

    image quality, faster 3D image acquisition and improved ease-of-use and workflow during surgical procedures using intraoperative MRI. The FDA cleared the advancements in February 2014 and the EC cleared them last month. Post your comment!

  6. Nektar Therapeutics Has More To Give

    Headlines

    Thu, 21 Aug 2014

    Soon Movantik, Nektar's PEGylated naloxol (also known as NKTR-118) has less than a month to go before it should receive FDA approval. This oral opioid antagonist has shown statistically significant efficacy versus placebo in multiple studies of opioid

  7. FDA clears da Vinci add-on

    Headlines

    Thu, 21 Aug 2014

    The FDA clears Intuitive Surgical's ( ISRG +1% ) Firefly Fluorescence Imaging feature that is used with the da Vinci Si System. Previously

  8. Ampio gets a "A" for creativity in its desire to use multi-injection study for Ampion BLA

    Headlines

    Thu, 21 Aug 2014

    of Ampion, the firm questions whether it should use the data in its BLA submission. The company has apparently contacted the FDA for guidance on the issue. Coincidentally, Ampio just happens to have a solution to the problem. It has 6-week interim data

  9. BRIEF-Biofrontera AG says pre-NDA meeting scheduled with FDA for approval of Ameluz and BF-RhodoLED

    Headlines

    Thu, 21 Aug 2014

    Aug 21 (Reuters) - Biofrontera AG : * Says pre-NDA meeting scheduled with FDA for the approval of Ameluz and BF-RhodoLED * Says has scheduled the pre-NDA (new drug application) meeting for 8 October

  10. New Morningstar Analyst Report for Eli Lilly and Co

    Stock Reports

    Thu, 21 Aug 2014

    unmet medical indications in neurology and oncology. The strategy should improve the success rate at the Food and Drug Administration , which has become exceedingly risk-sensitive to new drugs in well-treated areas such as cardiology

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