FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8-10 applicants chose...
CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device reviews and regulatory decisions to streamline their ...
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 ...
FDA warns Bausch and Lomb about CGMP violations at its Tampa, FL, drug manufacturing facility.
AstraZeneca says that its Etcamah (camizestrant) failed to significantly improve progression-free survival in the Phase 3 SERENA-4 trial testing the o...
