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 ...
FDA solicits comments on a report outlining a structure for a public/private partnership to establish and operate a repository of antimicrobial use da...
FDA approves an expanded indication for Mercks Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals 12 months of age and...
FDA clears an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to generate a report for ...
