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.
A self-described radical HHS policy now requires all new vaccines to be evaluated in placebo-controlled trials before theyre licensed for use, and thi...
FDA extends by three months its review of a Cytokinetics NDA for aficamten for treating patients with obstructive hypertrophic cardiomyopathy after re...
FDA approves a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine.
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...
