Eli Lilly says that an FDA review decision for its experimental Alzheimers drug donanemab has been pushed back to the first quarter of 2024.
FDA posts a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA...
The attorneys general from 25 states list six things FDA should do immediately to address the concern that pulse oximeters are not calibrated to work ...
CDRH asks for public comments on several questions to help it advance the development of digital health technologies for use in diabetes diagnosis.
FDA approves Abbotts Alinity m molecular human papillomavirus (HPV) diagnostic test.
FDA researchers look at manufacturing changes and comparability assessment of FDA-approved monoclonal antibodies and Fc-fusion products.
FDA grants I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membranous nephropathy.
