FDA and the Reagan-Udall Foundation announce a 3/29 virtual public workshop to discuss critical questions around access to naloxone and its use to rev...
Despite a statutory mandate, researchers say FDA has not increased post-approval trials with clinical endpoints for high-risk cardiovascular medical d...
FDA grants Myrtelle a Fast Track, Rare Pediatric Disease, and Orphan Drug designations for its lead clinical-stage gene therapy, rAAV-Olig001-ASPA, fo...
FDA approves a Kairos Pharma IND to begin a clinical trial of its activated T cell therapy (KROS 201) in patients with recurrent glioblastoma.
Federal Register notice: FDA seeks comments on its draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange for electr...
FDA releases the FDA-483s issued following two separate 2021 inspections at Chinas WuXi Biologics.
Two former JHL Biotech executives are sentenced to prison time and supervised release for conspiring to steal Genentech trade secrets and wire fraud.
FDA says a Celltrion USA recall of a Covid-19 rapid test due to a high rate of false-positive results is Class 1.