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.
Chemistry & Engineering News reports that reductions in CDER Division of Drug Information staff are affecting FDAs ability to maintain databases and r...
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...
