AstraZeneca urges FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors should start to colle...
FDA accepts for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and J...
Federal Register notice: FDA announces the revocation of two Monkeypox-related Emergency Use Authorizations after the authorization holders requested ...
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...
