Federal Register notice: FDA classifies coronary artery disease risk indicators using acoustic heart signals into Class 2 (special controls).
Sens. Cassidy and Hassan call on FDA and the Patent and Trademark Office to better coordinate and communicate on drug patent applications that could d...
FDA says it has pulled its approval of TG Therapeutics Ukoniq for two lymphoma indications due to safety concerns.
FDA launches a Web page, required by the 21st Century Cures Act, on antibacterial and antifungal susceptibility test interpretive criteria.
FDA grants breakthrough therapy designation to Sanofis efanesoctocog alfa to treat hemophilia A.
Researchers say CMS too often pays for drugs that received FDA accelerated approval but did not confirm a clinical benefit.
FDA removes a clinical hold against a Legend Biotech Phase 1 clinical trial of LB1901, an investigational autologous chimeric antigen receptor T-cell ...
FDA clears a Stryker 510(k) for its Q Guidance System for advanced planning and intraoperative guidance during open or percutaneous computer-assisted ...