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.
DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.
FDA warns Atlanta, GA-based Dr. Han Phan about failing to ensure that a clinical investigation followed the investigational plan.
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).
