Latest Headlines

Latest Headlines

FDA says Expedited Access PMA, new LDT regulations, will be implemented this year

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.

FDA draws line in sand over its orphan drug policies

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.

Daiichi Sankyo wins FDA nod for a new a-fib drug

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.

Court to give speedy answer in Actavis bid to yank old Namenda off market

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 receives FDA clearance for cableless fetal monitor

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.

Drug groups ask Supreme Court to pull constitutionality out from under California drug disposal law

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 wins an FDA nod after years of setbacks

Impax Laboratories finally won FDA approval for the Parkinson's disease treatment Rytary, capping a saga of delays, regulatory warnings and cutbacks.

FDA lifts import restriction on Hospira as it aims to reinvigorate its infusion pumps

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.

Impax Labs overcomes manufacturing issues to get Parkinson's drug approved

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.

Novartis clears an FDA hurdle with its pioneering biosimilar of Amgen's Neupogen

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.