FDA clears a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence model that uses deep learning for organs-at-risk segmentation.
FDA acccepts for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in certain o...
FDA rehires some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts.
The FDA Office of Scientific Integrity publishes a scheduling order for Vandas request for a hearing on a proposed CDER order to deny approval of the ...
The Associated Press reports FDA is attempting to rehire some travel support, food scientist, and Freedom of Information Act staff who were fired in r...
FDA approves the Element Science PMA for its Jewel Patch wearable cardioverter defibrillator.
FDA approves Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement platform for patients with severe aortic stenosis who show no sympt...
A Phase 3 trial funded by Novo Nordisk showed that its Ozempic/Wegovy outperformed placebo in patients with steatohepatitis and fibrosis.
