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.
Here's some good news for Lundbeck in an otherwise bleak week: The U.K.'s cost watchdog has endorsed its alcohol-dependence treatment, Selincro.
The FDA has decided that the death last month of a patient taking Biogen Idec's hot multiple sclerosis pill Tecfidera was important enough to mention on Tecfidera labels.
The battle is heating up over the FDA's draft guidance on the oversight of lab-developed tests, says the FDA Law Blog, which detailed both sides' actions over the last couple of weeks.
When Biogen Idec reported last month that a patient taking its hot multiple sclerosis pill Tecfidera had developed a rare brain infection and died, the drugmaker said it believed the safety profile of the drug remained solid. Perhaps so, but the FDA has decided the death was important enough to add a description of it on Tecfidera labels.