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 ...
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...
Sens. Hassan and Paul introduce a bill to require FDA to more clearly identify differences between a generic and its reference-listed drug.
FDA grants Novartis accelerated approval for Kymriah (tisagenlecleucel) for treating adult patients with relapsed or refractory follicular lymphoma af...
FDA denies most elements in four Consumers for Dental Choice petitions seeking additional agency actions to stop or reduce amalgam use in dentistry.
FDA approves two indications involving Bristol-Myers Squibbs Opdivo in combination with other drugs for some esophageal cancers.