Burlington, MA-based Flexion says that the FDA has lifted its clinical hold on its lead pain drug candidate, FX006.
Months after the U.K.'s drug price watchdog the National Institute for Health and Care Excellence gave a preliminary thumbs-down to Roche's Gazyvaro for chronic lymphocytic leukemia, the agency is now set to recommend the drug in new draft guidance with a few strings attached.
Cepheid scored an FDA OK to market its next-generation in vitro test for norovirus, helping the company generate some upward momentum as it ramps up its molecular diagnostic platform.
The U.S. Food and Drug Administration has approved the Animas Vibe, a combination insulin pump and continuous glucose monitor. It allows patients with Type 1 diabetes to monitor blood glucose levels and adjust insulin delivery based on that data.
The FDA has slapped Dr. Reddy's Laboratories with a Form 483 letter, outlining concerns about the drugmaker's manufacturing plant in southern India, the company said.
The FDA has branded Takeda's top late-stage drug prospect--ixazomib (MLN9708), a multiple myeloma treatment designed to succeed the top-selling blockbuster Velcade--as a "breakthrough" therapy deserving VIP status with regulators.
Medtronic scored EU regulatory approval for its $43 billion acquisition of Covidien, days after U.S. antitrust authorities signed off on the deal subject to certain conditions.
The FDA has slapped down Bristol-Myers Squibb's closely watched hep C drug daclatasvir, handing out a complete response letter for the linchpin drug in its cocktail strategy.
Industry applauded Japan's initiative to create a medical device regulatory regime distinct from that for pharmaceuticals.
Less than two weeks after losing longtime acquisition target Allergan--which happily sold itself to Actavis to dodge Valeant's hostile bid and the R&D cuts it feared would come along with it--the Canadian pharma is talking up the productivity of its own labs.