Federal Register notice: FDA renews its Antimicrobial Drugs Advisory Committee for an additional two years.
FDA names CDER Office of Generic Drugs safety and clinical evaluation acting director Iilun Murphy as the next OGD director, replacing Sally Choe, who...
FDA greenlights commercial production of CAR T cell therapy at a new Bristol Myers Squibb manufacturing site in Devens, MA.
FDAs Antimicrobial Drugs Advisory Committee votes unanimously that AstraZeneca and Sanofis nirsevimab has a favorable benefit-risk assessment for prev...
FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.
AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and also recommends change...
FDA clears a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire a bipolar temporary device designed specifically for use during transcatheter...
Federal Register notice: FDA makes available a draft guidance entitled E6(R3) Guideline for Good Clinical Practice.
