Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek increased enforcemen...
FDA says it has identified serious liver injuries in patients without cirrhosis of the liver being treated for primary biliary cholangitis with Interc...
Keros Therapeutics stops some dosing in a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulm...
A detailed ProPublica investigative report says FDA failed to inspect a Glenmark Pharmaceuticals facility in India that had multiple drug recalls in a...
In a Time interview, president-elect Donald Trump said it has always been his commitment to preserve access to abortion pills, but also said the issue...
The Association for Accessible Medicines urges Congress to pass pending legislation to allow FDA to disclose sameness information about a brand drug t...
FDA launches the CDER Center for Real-World Evidence Innovation with four areas of initial focus.
An IQVIA analysis of novel active substance approvals from 2014 to 2022 in the U.S., EU, and Japan shows the U.S. approves more new drugs and approves...
