Sen. Richard Blumenthal (D-CT) calls on the Justice Department to take action against Philips Respironics after a recent investigation by ProPublica a...
FDA approves an Arcutis Biotherapeutics supplemental NDA to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of pla...
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.
