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).
FDA awards Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome.
FDA warns Chinas YouQuan Care Products about CGMP violations in its manufacturing of finished drugs.
