Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in patients with focal o...
Ipsen voluntarily withdraws Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 trial due to safety ...
FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an in...
A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.
HHS says CBER director Vinay Prasad will step down at the end of April.
An FDA official discussing an ongoing dispute with UniQure raises concerns with outside experts who sit on agency advisory committees.
FDA says an expanded recall by Medline Industries involving certain reprocessed electrophysiology and ultrasound catheters has been classified as Clas...
FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to ...
