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FDA Releases 14 New Drug Rejection Letters After 3‑Month Pause in Transparency Policy

The Francis Crick Institute and Medicines Discovery Catapult Open KQ Labs Applications, Accelerating the Next Wave of Data-Driven Health Innovation

Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

FDA Misses IND Deadline for Coya's ALS Asset, Citing Resource Constraints

Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss