FDA grants Myrtelle a Fast Track, Rare Pediatric Disease, and Orphan Drug designations for its lead clinical-stage gene therapy, rAAV-Olig001-ASPA, fo...
Federal Register notice: FDA seeks comments on an information collection extension for abbreviated new animal drug applications.
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.
FDA seeks comments on an information collection extension for medical device accessories.