FDA grants Onc.AI a breakthrough device designation for its Serial CT Response Score AI model, which the company describes as an artificial intelligen...
FDA says the Medline Industries recall of integrated arterial catheters is Class 1.
Mainstream media reports based on anonymous sources say the White House is preparing an order to require HHS to fire a percentage of employees in FDA,...
A Buchanan Ingersoll petition asks FDA to maintain restrictions on cancer drug Tabloid ANDAs that are in the applicable product-specific guidance.
FDA grants Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection for detecting are...
An FDA safety alert on certain diabetes devices that rely on a smartphone to deliver critical safety alerts warns that these may malfunction at times.
A Bloomberg Law report says New York is the latest state to indicate an interest in the FDA pathway to import lower-cost drugs from Canada.
Kura Oncology and Kyowa Kurin say they expect to submit a ziftomenib NDA to FDA in the second quarter of 2025.
