FDA approves Novartis Radioligand Therapy manufacturing facility in Indianapolis, IN, to produce prostate cancer therapy Pluvicto.
FDA leaders say anti-vaxxers and those that are vaccine-hesitant due to safety concerns or religious beliefs are threatening U.S. public health by ris...
FDA issues ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection documented GMP violations.
Rep. Gregory Murphy asks FDA for its views on several aspects of using artificial intelligence in medical care as a prelude to regulatory legislation.
ROi CPS of Republic, MO, recalls its Regard Wound Dressing change kit due to it containing nonconforming material/component.
Federal Register notice: FDA makes available a draft document entitled Food and Drug Administrations Draft Report and Plan on Best Practices for Guida...
FDA says it is evaluating the need for regulatory action after seeing a safety signal for some additional side effects in GLP-1 receptor agonists like...
FDA clears a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner.
