Atrium Medical recalls its iCast Covered Stent System after receiving increased customer complaints about the balloon or catheter hub separating from ...
Three doctors sue FDA over the agencys efforts to prevent the use of ivermectin to treat Covid-19.
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...
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.