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 accepts for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and J...
FDAs Oncologic Drugs Advisory Committee votes 10 to 2 that the CodeBreak 200 confirmatory study cannot be reliably interpreted as the basis for Amgens...
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.
