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  1. UPDATE 1-Hikma Pharma says US FDA issues warning on Portugal plant

    Headlines

    Fri, 24 Oct 2014

    Oct 24 (Reuters) - Drugmaker Hikma Pharmaceuticals Plc said the U.S. health regulator had raised issues related to investigations and environmental monitoring at its plant in Portugal.

  2. Hikma Pharma says US FDA issues warning on Portugal plant

    Headlines

    Fri, 24 Oct 2014

    Oct 24 (Reuters) - Drugmaker Hikma Pharmaceuticals Plc said the U.S. Food and Drug Administration had raised issues related to investigations and environmental monitoring at its plant in Portugal.

  3. BRIEF-Hikma says gets warning from U.S. FDA on Portugal manufacturing unit

    Headlines

    Fri, 24 Oct 2014

    * Received a warning letter from U.S. Food and Drug Administration on Oct 23, 2014 related to inspection of its manufacturing facility in Portugal in march 2014

  4. FDA extends Natpara PDUFA date

    Headlines

    Thu, 23 Oct 2014

    FDA extends Natpara PDUFA date

  5. Axiron Sales Soften, FDA Overhang Persists; Fair Value Estimate Unchanged

    Commentary

    Thu, 23 Oct 2014

    product despite the issues raised by the FDA related inquiry into safety of the testosterone therapy category as a whole. The FDA is expected to provide a definitive ruling ..... potential impact of an adverse ruling by the FDA on prescribing patterns for Axiron in the

  6. FDA extends review date for NPS Pharma hormone replacement therapy

    Headlines

    Thu, 23 Oct 2014

    Oct 23 (Reuters) - NPS Pharmaceuticals Inc said the U.S. Food and Drug Administration had extended the review date for its hormone replacement therapy by three months to provide time for a full...

  7. BioMarin's 3Q Strong on Vimizim Launch, and We Remain Bullish on 2015 Pipeline Data

    Commentary

    Thu, 23 Oct 2014

    products could slow within the next few years, as Naglazyme market penetration is high, and Dr. Reddy's filed an ANDA with the FDA for a generic version of Kuvan (BioMarin's infringement suit should mean a 30-month stay and a launch delayed until 2017

  8. CR Bard is Set to See Growth from its U.S. Lutonix Balloon Launch

    Commentary

    Thu, 23 Oct 2014

    flexibility to support development and commercialization efforts in the near term. We were surprised and pleased to see early FDA approval of Bard's new Lutonix drug-eluting balloon. Strong European uptake of Lutonix fueled 9% quarterly growth in the

  9. Boston Scientific's Strong 3Q Fueled by Stellar Stent Performance

    Commentary

    Wed, 22 Oct 2014

    We are most intrigued by the Watchman left atrial appendage closure device, which recently received a favorable vote from the FDA panel on its third try. Considering there is a significant minority of atrial fibrillation patients (estimated at 14-44

  10. New Products and Manufacturing Improvements Suggest Ongoing Progress for BioMerieux

    Commentary

    Wed, 22 Oct 2014

    company to face ongoing challenges from sluggish sales in Europe in addition to industrial segment headwinds in China. Another FDA warning letter issued in October for the company's VITEK production in St. Louis, Missouri, should not materially affect

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