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Require Prednisolone Solution Studies: DifGen

[ Price : $8.95]

DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.

Clinical Investigator Didnt Meet Requirements: FDA

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FDA warns Atlanta, GA-based Dr. Han Phan about failing to ensure that a clinical investigation followed the investigational plan.

Draft Guide on Antibacterial Bovine Drugs

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Federal Register notice: FDA makes available a draft revised guidance entitled Evaluating Target Animal Safety and Effectiveness o...

Guide on Change Control Plans for AI Devices

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Federal Register notice: FDA makes available a final guidance entitled Marketing Submission Recommendations for a Predetermined Ch...

Lillys Zepbound Shows Superiority Over Wegovy: Trial

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In a head-to-head trial, Eli Lillys weight-loss drug Zepbound (tirzepatide) shows superiority over Novo Nordisks Wegovy (semagluti...

Breakthrough Status for Dravet Therapy

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FDA awards Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome.

Shortage of Empty IV Containers

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FDA adds empty IV containers to the medical device shortages list and says the shortage is likely to last until 3/2025.

FDA Clears Zimmer Persona Femur

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FDA clears the Zimmer Biomet Persona SoluTion total knee replacement component for patients with sensitivities to bone cement or m...

Merus Bizengri Wins Accelerated Approval

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FDA grants Merus accelerated approval for Bizengri (zenocutuzumab-zbco) for certain adults with advanced, unresectable, or metasta...

Drug-Induced Liver Injury Indicator Seen: FDA

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FDAs National Center for Toxicological Research finds a new predictor for drug-induced liver injury.