The FDA promised to finalize an expedited approval pathway for medical devices that address critical unmet needs and to officially expand its authority into the regulation of lab-developed molecular diagnostic tests in its annual list of upcoming medical device-related guidance documents for the new year.
The FDA says it will abide by a court ruling stating it has to grant orphan drug exclusivity to Depomed's Gralise. But the agency has drawn a line in the sand, saying it does not intend to extend the same benefit to any other drugmakers under the same circumstances.
The FDA signed off on Daiichi Sankyo's clot-preventing edoxaban, giving the Japanese drugmaker the green light to compete in a crowded market for next-generation anticoagulants.
Actavis is waiting eagerly to find out whether it can move forward with its plans to force patients over to a new, patent-protected version of blockbuster Alzheimer's treatment Namenda. And its waiting period just got shorter.
Philips announced FDA clearance of its Avalon CL Fetal Monitoring solution to monitor pregnant women without the use of cables, enabling more freedom of movement during labor.
Having been unable to persuade a federal court or an appeals court that a California county's mandate that drugmakers pay for the disposal of unused meds was off base, PhRMA, BIO and GPhA are going to the ultimate arbiter of legal matters, the U.S. Supreme Court.
Impax Laboratories finally won FDA approval for the Parkinson's disease treatment Rytary, capping a saga of delays, regulatory warnings and cutbacks.
Hospira vowed to cut old product lines, address its production problems and invigorate innovation in its medical devices business as part of a grand plan revealed on May 1, 2013. Now it's making some progress as it said FDA had lifted an import alert that had prohibited import of infusion pump devices manufactured in its Costa Rica plant.
Following several years of delays tied to manufacturing issues, the FDA has given the OK to Impax Laboratories' Parkinson's disease drug Rytary. The approval ends a saga for the Hayward, CA-based company that started with a warning letter and led to leadership changes, a securities lawsuit and severe staff cuts.
A group of FDA advisers unanimously recommended approval for Novartis' knockoff of a blockbuster Amgen treatment, clearing the way for what would be the first U.S. approval of a copycat biologic medicine.