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 ...
Lexeo Therapeutics says it will explore with FDA the potential to seek accelerated approval for LX2006 and its use in treating Friedreich ataxia cardi...
