Apricus Biosciences says it cant afford to do what FDA says is needed for a Vitaros NDA resubmission and it is shopping the U.S. rights to the erectil...
FDA releases an FDA-483 with seven observations from an inspection at Englewood, CO-based Denver Solutions outsourcing facility.
FDA approves a new Jardiance indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
FDA clears a Viz.ai 510(k) for the Viz Aneurysm module and its use on the Viz Intelligent Care Coordination Platform for detecting suspected cerebral ...
FDA extends its review of a United Therapeutics NDA resubmission for Tyvaso DPI (inhaled treprostinil) after receiving an information request letter f...
Federal Register notice: FDA publishes a proposed rule to amend medical device current GMP requirements of the Quality System Regulation to align more...
FDA says it will open notice-and-comment rulemaking to analyze the impact of a memorandum of understanding between it and states on the distribution o...
Three stakeholders comment on an FDA draft guidance on technical considerations for medical devices with physiologic closed-loop control technology.