An FDA advisory committee votes 16-2 in support of approving a Lumicell NDA for Lumisight (pegulicianine), an optical imaging agent for use in patient...
FDA clears a Getinge 510(k) for the Vasoview Hemopro 3, a third-generation endoscopic vessel harvesting device.
FDA approves Novo Nordisks weight loss drug Wegovy (semaglutide) injection for reducing the risk of cardiovascular death, heart attack and stroke in a...
FDA pushes back its review decision on Eli Lillys experimental Alzheimers drug donanemab by requiring an advisory committee to discuss the Phase 3 TRA...
Amylyx Pharmaceuticals considers withdrawing its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate and taurursodiol) after announcing...
Federal Register notice: FDA revokes an Eli Lilly emergency use authorization for bamlanivimab and etesevimab administered together for treating Covid...
KVK Research and KVK Tech of Bucks County, PA, plead guilty to introducing adulterated drugs into interstate commerce and agree to pay a $1.5 million ...
Novo Nordisk says its experimental weight-loss pill amycretin achieved a 13.1% weight loss in participants in a Phase 1 trial.
