FDA issues Incyte a complete response letter on its BLA for retifanlimab, an intravenous PD-1 inhibitor for treating certain adult patients with local...
Federal Register notice: FDA announces a 9/2-3 Cellular, Tissue and Gene Therapies Advisory Committee meeting.
Federal Register notice: FDA rescinds a 1/15 notice that identified seven types of reserved Class 1 devices that HHS had determined no longer require ...
FDA issues Iterum Therapeutics a complete response letter on its NDA for sulopenem etzadroxil/probenecid, indicated for treating treat multi-drug resi...
Federal Register notice: FDA extends the comment period for a 6/15 notice on: Exemption from Premarket Notification: Powered Patient Transports.
Federal Register notice: FDA and the Clinical Trials Transformation Initiative request applications for patient advocates interested in participating ...
FDA revises a Manual of Policies and Procedures (MAPP) entitled Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, an...
Bristol Myers Squibb withdraws an indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma who were previously t...