FDA lifts a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia...
FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distributed Covid-19 test...
FDA posts a draft guidance entitled Benefit-Risk Considerations for Product Quality Assessments, which describes the agencys benefit-risk principles u...
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Federal Register notice: FDA makes available a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Vo...
Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Testosterone.