FDA clears a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery.
Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Drug Promotion research into implied claims in direct...
The CDER Office of Generic Drugs 2023 annual report details the 956 ANDAs approved or tentatively approved last year.
Two Hogan Lovells attorneys and two Greenleaf Health executives discuss FDA actions in this election year at a recent J.P. Morgan healthcare conferenc...
FDA grants Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy platform that is intended to treat adults with m...
Federal Register notice: FDA makes available a final guidance entitled Assessing Covid19-Related Symptoms in Outpatient Adult and Adolescent Subjects ...
Federal Register notice: FDA debars Taylor McLaren for five years from importing or offering for import any drug into the U.S.
FDA accepts for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating certain adult patients with locally adv...
