The agency advisers weren't unanimous in backing GSK's follow-up to now-off-patent Advair, however.
Manufacturing problems are again standing in the way of a drug launch, with the FDA holding off approval of Allergan's ($AGN) new migraine treatment until problems at an inhaler plant are sorted out.
One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies.
Hyperion has won its first FDA approval. The South San Francisco-based company grabbed the agency's nod for its drug Ravicti, a treatment for managing genetic conditions known as urea cyclic disorders.
Abbott ($ABT) this week launched a massive U.S. clinical trial for its Absorb drug-eluting bioresorbable vascular scaffold, with plans to enroll up to 2,250 patients. If the results pass muster, they'll support the company's FDA approval bid.
The FDA has approved Rebif Rebidose, a single-use auto-injector prefilled with Merck and Pfizer's interferon beta-1a, for the treatment of multiple sclerosis.
For Johnson & Johnson, jury selection is scheduled to begin Jan. 7 for one of 1,800 lawsuits in New Jersey state court accusing the company of selling unsafe vaginal mesh implants without warning patients of the dangers.
Last year turned out to be a record-setter for new drug approvals in the U.S. The FDA blessed 39 new molecular entities (NMEs) in 2012, even more than the 35 racked up in 2011. Two years of strong numbers have some experts heralding a new era of productivity for biopharma R&D. Read more and check out the slideshow >>
Abbott ($ABT) is pursuing an immediate U.S. rollout of its next-generation Xience Xpedition drug eluting stent, backed by a long-awaited FDA approval announced Jan. 3. Four months ago, the product gained a CE mark in Europe.
Dune Medical Devices' headline-grabbing cancer tool has capped its rapid road through the FDA with a full pre-market approval, getting the agency's sign-off for marketing in the U.S.