FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.
FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.
FDA clears a Smith+Nephew 510(k) for its new Catalystem Primary Hip System.
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 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...
