CBER director Peter Marks tells a House briefing that FDA is not delaying its review of Modernas Covid-19 vaccine for children under five years old so...
FDA lifts a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia...
Federal Register notice: FDA announces that it is withdrawing approval of Bristol Myers Squibbs (Celgene) peripheral T-cell lymphoma indication for Is...
Federal Register notice: FDA announces a 6/8 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances that have been nomin...
Federal Register notice: FDA makes available a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Vo...
Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Testosterone.
FDA Review posts the the Federal Register notices for the week ending 5/6/2022.