FDA warns the MIT IRB on using humans as experimental subjects about repeat violations of regulations.
FDA gives DiscGenics the go ahead for a Phase 3 clinical trial after agreeing to the clinical protocols and chemistry, manufacturing, and controls cli...
FDA gives Orexo AB a complete response letter on its NDA for OX124, a high-dose naloxone rescue medication for opioid overdose.
FDA gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treating pediatric acute m...
Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyelinating polyneuropath...
Federal Register notice: FDA announces the Cellular and Gene Therapies Interactive Site Tours Program that is intended to give CBER reviewers an oppor...
FDA grants Sumitomo Pharma America a fast track designation for DSP-5336 and its use in treating certain patients with relapsed or refractory acute my...
FDA posts a guidance entitled Drugs for Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients One Month of ...
