Federal Register notice: FDA corrects a 2/22 notice announcing the availability of a final guidance on assessing Covid19-related symptoms in outpatien...
Federal Register notice: FDA announces a 5/9 Blood Products Advisory Committee meeting on strategies to reduce the risk of transfusion-transmitted mal...
Johnson & Johnson files a supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis.
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...
