Jones Day attorneys update FDAs commitments for a regulatory framework to address artificial intelligence as a tool for advancing medical therapeutics...
FDA clears a bioMrieux 510(k) for its Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury.
FDA accepts for priority review a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoietic stem c...
FDA publishes 48 new and revised product-specific guidances in its latest batch.
Federal Register notice: FDA withdraws the approval of seven ANDAs from multiple applicants after they notified the agency that the drugs are no longe...
North American Diagnostics recalls its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without FDA authorization, clearanc...
FDA issues a clinical hold on Beam Therapeutics BEAM-201 and its use in treating relapsed/refractory T-cell acute lymphoblastic leukemia/T cell lympho...
Federal Register notice: FDA seeks comments on an information collection entitled Reporting Associated With Designated New Animal Drugs for Minor Use ...
