FDA publishes a guidance on how it calculates combination product application user fees.
FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control i...
FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.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.
