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.
Republican members of the House Energy and Commerce Committee express concern about FDA inaction on the safety of agency laboratory operations and the...
A transition to an improved manufacturing process leads to an FDA partial clinical hold on a Nurix Therapeutics clinical study evaluating NX-2127 in v...
Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date.
FDA says it will continue to exercise enforcement discretion for some supplements to PMAs and HDEs.
