GSK says it will submit an NDA by 6/30 for antibiotic gepotidacin and its use in treating uncomplicated urinary tract infections.
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.
