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.
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.
* 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
FDA extends Natpara PDUFA date
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
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...
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
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
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
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