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  1. FDA tags Lymphoseek an Orphan Drug

    Headlines

    Thu, 18 Sep 2014

    The FDA designates Navidea Biopharmaceuticals' ( NAVB +14% ) Lymphoseek ( technetium Tc 99m tilmanocept) an Orphan Drug for use in

  2. FDA clears Trulicity

    Headlines

    Thu, 18 Sep 2014

    The FDA approves Eli Lilly's ( LLY +1.1% ) Trulicity ( dulaglutide ), a once-weekly subcutaneous injection to improve glycemic

  3. CORRECTED-UPDATE 1-Vivus' Stendra gets FDA approval for use 15 minutes before sex

    Headlines

    Thu, 18 Sep 2014

    (Corrects headline and first paragraph to make clear that Stendra was already approved for use 30 minutes before sex, and has now been approved for use as little as 15 minutes before sex)

  4. CORRECTED-Vivus' Stendra gets FDA approval for use 15 minutes before sex

    Headlines

    Thu, 18 Sep 2014

    (Corrects headline and first paragraph to make clear that Stendra was already approved for use 30 minutes before sex, and has now been approved for use as little as 15 minutes before sex)

  5. FDA clears Siemens CT scanner

    Headlines

    Thu, 18 Sep 2014

    The FDA approves Siemens Healthcare's lower-priced Somatom Scope CT scanner. The 16-slice scanner is designed use in private radiology

  6. FDA clears da Vinci for benign transoral procedures

    Headlines

    Thu, 18 Sep 2014

    The FDA approves Intuitive Surgical's (NASDAQ: ISRG ) da Vinci S and da Vinci Si Surgical Systems for use in benign base of tongue

  7. BRIEF-Eos Imaging receives FDA clearance for new software

    Headlines

    Thu, 18 Sep 2014

    * Said on Wednesday has received FDA clearance for software dedicated to sagittal balance and posture analysis Source text for Eikon: [ID: nBw8XM3T8a] Further company coverage:

  8. Ad Comm says TRT drug makers should conduct new trials to assess heart risk

    Headlines

    Thu, 18 Sep 2014

    a causal link between TRT and cardiovascular events. Based on the committee's statements, though, it will work with the FDA on how to communicate the cardiovascular risk to patients. The committees meet today to discuss Clarus Therapeutics' NDA for

  9. FDA clears Stendra label expansion

    Headlines

    Thu, 18 Sep 2014

    The FDA approves a label expansion for Vivus' (NASDAQ: VVUS ) erectile dysfunction (ED) drug Stendra ( avanafil ) that reduces the

  10. IPO Preview: ProQR Therapeutics

    Headlines

    Thu, 18 Sep 2014

    fibrosis . PRQR has had positive preclinical results and plans to file in Q4 2014 an IND (investigational new drug) with the FDA . In August 2014, PRQR entered into an agreement with Cystic Fibrosis Foundation Therapeutics to provide PRQR with up Complete

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