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.
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Federal Register notice: FDA releases a revised draft guidance entitled Assessing the Irritation and Sensitization Potential of Transdermal and Topica...
FDA sends Eli Lilly a complete response letter on its BLA for mirikizumab and its use for treating ulcerative colitis.
Federal Register notice: FDA makes available a revised draft guidance Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.
