FDA adds empty IV containers to the medical device shortages list and says the shortage is likely to last until 3/2025.
FDA clears the Zimmer Biomet Persona SoluTion total knee replacement component for patients with sensitivities to bone cement or metal.
FDA grants Merus accelerated approval for Bizengri (zenocutuzumab-zbco) for certain adults with advanced, unresectable, or metastatic non-small cell l...
FDAs National Center for Toxicological Research finds a new predictor for drug-induced liver injury.
FDA warns Chinas YouQuan Care Products about CGMP violations in its manufacturing of finished drugs.
Roivants Kinevant Sciences unit halts the development of namilumab for treating sarcoidosis after a Phase 2 study failed to show treatment benefit.
FDA issues a report and plan on best practices for guidances, incorporating comments from a 2023 draft report and plan.
FDA publishes a guidance with recommendations for marketing submissions for Predetermined Change Control Plans for artificial intelligence-enabled dev...
