Due to an earlier Nurse Assist, LLC product recall, Cardinal Health is recalling products supplied to it for use in Covidien and Cardinal Health brand...
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...
Congressman Mike Waltz (R-FL) asks FDA for clarification on the agencys telework policies which have minimized the operational standards for approving...
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...
