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  1. FDA rejects Avanir's migraine drug-device

    Headlines

    Wed, 26 Nov 2014

    Nov 26 (Reuters) - The U.S. Food and Drug Administration rejected Avanir Pharmaceuticals Inc's migraine drug device, a few weeks after the regulator had raised questions regarding some data submitted...

  2. UPDATE 1- FDA declines to approve Bristol-Myers hepatitis drug

    Headlines

    Wed, 26 Nov 2014

    (Adds details on drug, other Bristol-Myers, rival treatments)

  3. FDA declines to approve Bristol-Myers hepatitis drug

    Headlines

    Wed, 26 Nov 2014

    Nov 26 (Reuters) - Bristol-Myers Squibb Co on Wednesday said U.S. regulators had declined to approve use of its experimental daclatasvir drug for hepatitis C, in combination with other antiviral drugs.

  4. BRIEF-Zeltia SA's soft tissue sarcoma drug submitted to U.S. FDA

    Headlines

    Tue, 25 Nov 2014

    * Said on Monday Janssen Research & Development LLC submitted a New Drug Application (NDA) for Yondelis to the U.S. Food and Drug Administration for the treatment of patients with advanced soft tissue sarcoma (STS)

  5. Novartis says U.S. FDA extends review period for bone marrow drug

    Headlines

    Tue, 25 Nov 2014

    ZURICH, Nov 25 (Reuters) - Swiss drugmaker Novartis AG said on Tuesday the U.S. Food and Drug Administration ( FDA ) had extended a priority review period by up to three months for a new drug application for the treatment of a type of bone marrow cancer.

  6. Draft U.S. legislation would curb FDA medical software oversight

    Headlines

    Mon, 24 Nov 2014

    SAN FRANCISCO, Nov 24 (Reuters) - A draft U.S. bill is circulating in Washington D.C. that would curb the U.S. Food and Drug Administration 's regulatory oversight over electronic medical records and...

  7. FDA tightens guidelines on technique for uterine fibroid surgery

    Headlines

    Mon, 24 Nov 2014

    WASHINGTON, Nov 24 (Reuters) - The U.S. Food and Drug Administration has tightened its guidelines on the use of a uterine surgical technique, saying it has been linked to the spread of a rare type of cancer.

  8. BioMarin's Prosensa Acquisition Appears to Be a Great Fit at a Good Price

    Commentary

    Mon, 24 Nov 2014

    BioMarin's portfolio of rare disease therapies. While the DMD landscape is poised to become competitive--Sarepta is completing its FDA filing for similar drug eteplirsen in the middle of 2015—we think BioMarin's backing and potential first-to-market position

  9. CORRECTED- FDA approves Purdue's painkiller that can reduce abuse

    Headlines

    Fri, 21 Nov 2014

    (In Nov. 20 story, corrects final paragraph to show Embeda treats pain, not opioid dependence)

  10. BRIEF-Basilea Pharmaceutica says FDA sets date of advisory committee meeting on isavuconazole NDA

    Headlines

    Fri, 21 Nov 2014

    * Reports that U.S. FDA sets date of advisory committee meeting on isavuconazole NDA for the treatment of invasive aspergillosis and mucormycosis

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