FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.
FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as it ramps up enforcem...
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.
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of ...
