A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...
In July 2025, the US Food and Drug Administration (FDA) announced a pilot program intended to expedite reviews for drug applications that met one of five national priorities, including products deemed ...
A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
NDA submission based on the Phase 2b REZILIENT1 clinical trial, which demonstrated clinically meaningful and durable responses in patients with relapsed EGFR exon 20 insertion–mutated NSCLC ...
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