FDA associate commissioner for regulatory affairs Judith McMeekin announces her retirement after 15 years at the agency, observing that further retire...
FDA approves a Gamida Cell Ltd. BLA for Omisirge (omidubicel-onlv), a modified allogeneic cord blood-based cell therapy to speed recovery of neutrophi...
Federal Register notice: FDA announces a 6/7-8 public workshop entitled Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for ...
Federal Register notice: FDA announces the issuance of an emergency use authorization to Cue Health for the Cue Mpox (Monkeypox) Molecular Test.
A joint advisory committee meeting votes 9 to 1 that an Otsuka Pharmaceutical and Lundbeck a sNDA for Rexulti (brexpriprazole) provided sufficient dat...
FDA clears an Abbott 510(k) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring system.
Avenue Therapeutics meets with FDA to map out a plan for resubmitting a twice-rejected NDA for intravenous tramadol for treating post-operative pain.
Federal Register notice: FDA releases a revised draft guidance entitled Assessing the Irritation and Sensitization Potential of Transdermal and Topica...
