Vertex Pharmaceuticals plans to file an NDA by mid-year and use a priority review voucher for its cystic fibrosis combination drug, once-daily vanzaca...
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.
Congressman Mike Waltz (R-FL) asks FDA for clarification on the agencys telework policies which have minimized the operational standards for approving...
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.
