FDA clears a Hologic 510(k) for its Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a digital cytology system for identifying...
FDA approves Edwards Lifesciences Evoque tricuspid valve replacement system for treating tricuspid regurgitation.
FDA grants Tyra Biosciences a rare pediatric disease designation for TYRA-300, an oral FGFR3 selective inhibitor for treating achondroplasia (dwarfism...
Cardinal Health recalls all sizes of its Monoject sterile Syringe Luer-Lock Tip Soft Packs and Monoject sterile Enteral Syringes with ENFit connection...
A new online commentary by two CDER Office of Medical Policy officials outlines the advantages and challenges of conducting decentralized clinical tri...
Federal Register notice: FDA announces a 3/15 Oncologic Drugs Advisory Committee meeting to discuss sBLAs for Janssens Carvykti and Celgenes Abecma.
Seven former FDA commissioners file an amicus brief with the Supreme Court urging that a lower court ruling restricting access to the abortion drug mi...
FDA Commissioner Robert Califf says artificial intelligence (AI) embedded in clinical decision support or the integration of AI into clinical practice...
