Syndax Pharmaceuticals says new positive data justifies stopping the pivotal AUGMENT-101 trial of revumenib in adult and pediatric patients with relap...
FDA commissioner Robert Califf addresses the Reagan-Udall Foundation about its new report on misinformation and observes the agency faces a daunting t...
FDA clears a Sanguina 510(k) for the AnemoCheck Home, a home-use hemoglobin test kit.
FDA places a partial clinical hold on the Innate lacutamab IND to treat two forms of T-cell lymphoma following a patient death in one of the companys ...
FDA touts the 10th anniversary of the CDRH cybersecurity program, highlighting several program achievements.
Reps. Bucshon and DeGette call on Congress to pass the VALID Act in response to FDAs proposed rule on laboratory-developed tests.
FDA grants Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associated with hereditary...
Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting to discuss proposed cl...
