Federal Register notice: FDA makes available a draft revised guidance entitled Evaluating Target Animal Safety and Effectiveness of Antibacterial New ...
Federal Register notice: FDA makes available a final guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan fo...
In a head-to-head trial, Eli Lillys weight-loss drug Zepbound (tirzepatide) shows superiority over Novo Nordisks Wegovy (semaglutide).
FDA awards Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome.
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.
