The CDER Office of Clinical Pharmacology launches a Web site to give healthcare professionals examples of drug interactions involving CYP enzymes and ...
FDA approves an expanded indication for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) for treating pediatric patients aged one to 11 year...
FDA clears an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triaging pneumothorax and...
Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices authorized in 2023.
Federal Register notice: FDA makes available a draft guidance entitled Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs) Used i...
CBER says Lewisburg, TN-based Vitacell Biologics is illegally marketing cellular and exosome products.
FDA releases the form FDA-483 with two inspection observations issued to Columbus, OH-based STAQ Pharma of Ohio.
CBER executives say FDA is aware of a relatively small number of cases in which people treated with CAR-T products developed secondary cancers that ma...
