Abbott recalls its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start.
President Biden seeks a $500 million boost in FDAs spending in fiscal year 2025, which is 7.4% more than the current $6.7 billion spending level in FY...
FDA posts a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment with a focus on the ultimate goal of delaying or halting/...
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.
