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.
Roivants Kinevant Sciences unit halts the development of namilumab for treating sarcoidosis after a Phase 2 study failed to show treatment benefit.
