FDA sends an untitled letter to Incyte Corp., warning that portions of the companys consumer-facing Web site for Niktimvo (axatilimab-csfr) contain fa...
CDER's Office of Compliance releases a new annual report showing that it expanded enforcement and oversight activities in 2025.
FDA raises multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, following an inspection in ...
FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes included in medical conve...
FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to reach Medicare patient...
FDA sends Grace Therapeutics a complete response letter rejecting approval for its experimental treatment GTx-104 (nimodipine), citing outstanding man...
A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Courts Loper Bright de...
FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.
