FDA approves an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating acute migraine.
FDA approves a BlackSwan Vascular PMA for its Lava Liquid Embolic System for treating peripheral arterial hemorrhage.
Hogan Lovells attorney David Fox says Intarcia has several concerns about the fairness of an advisory committee meeting that the company agreed could ...
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.
