Federal Register notice: FDA makes available a final guidance entitled Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the...
Federal Register notice: FDA determines that KTAB (potassium chloride) extended-release tablets were not withdrawn due to safety or effectiveness conc...
Federal Register notice: FDA permanently debars Raidel Figueroa from providing services in any capacity to a person that has an approved or pending dr...
Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, which is studying the combination use with a full-dose o...
FDA discusses a new drug safety initiative that aims to develop artificial intelligence models for toxicological endpoints that are key to assessing d...
FDA releases a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).
FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host d...
FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy workflow to perform ...
