A RealClear Health column urges FDA not to overcorrect as it reconsiders its approach to investigational rare disease therapies.
Gilead petitions FDA to rescind its acceptance for filing of two Zydus 505(b)(2) applications for drugs that Gilead says are duplicates of its Descovy...
FDA clears a Neptune Medical 510(k) for its Triton 1 System, a robotic system for next-generation flexible endoscopy.
Sen. Elizabeth Warren says she is continuing to push Trump officials to release the actual contracts that have been signed with drug companies that ar...
Stakeholders stress issues involving access and safety at an FDA hearing on psychedelic drug regulation.
FDA agrees to key elements of Rocket Pharmaceuticals modified pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the company to continue enr...
Six House members introduce bipartisan legislation to make the FDA Rare Pediatric Disease Priority Review Voucher Program permanent.
Senate HELP Committee chairman Bill Cassidy (R-La.) keeps mum on any potential support for FDA commissioner nominee Heidi Overton following a meeting ...
