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...
FDA approves a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine.
Reps. Alexandria Orcasio-Cortez and Nydia Velzquez ask HHS secretary Robert F. Kennedy, Jr., to reopen the FDA San Juan medical products laboratory th...
