Federal Register notice: FDA corrects a 9/19 notice entitled Food and Drug Administration Information Technology Strategy; Request for Comments.
FDA approves Novartis intravenous Cosentyx (secukinumab) formulation for treating adults with psoriatic arthritis, ankylosing spondylitis and non-radi...
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 ...
