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DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.[ Price : $8.95]
FDA warns Atlanta, GA-based Dr. Han Phan about failing to ensure that a clinical investigation followed the investigational plan.[ Price : $8.95]
Federal Register notice: FDA makes available a draft revised guidance entitled Evaluating Target Animal Safety and Effectiveness o...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Marketing Submission Recommendations for a Predetermined Ch...[ Price : $8.95]
In a head-to-head trial, Eli Lillys weight-loss drug Zepbound (tirzepatide) shows superiority over Novo Nordisks Wegovy (semagluti...[ Price : $8.95]
FDA awards Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome.[ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher to PTC Therapeutics for its qualified rare pediatric disease product...[ Price : $8.95]
Federal Register notice: FDA reopens the comment period associated with a 10/21 public meeting on Advancing Smoking Cessation: Foo...