GSK-Spero’s oral antibiotic tebipenem pivoxil hydrobromide, branded Utebzi, received U.S. FDA approval for complicated urinary tract infections (cUTI), including pyelonephritis. The approval came four years after the agency issued a complete response letter for the same program. The FDA decision was based on Phase 3 data demonstrating noninferiority to IV imipenem-cilastatin. The company said Utebzi is expected to be available by the end of 2026. Under an existing $600 million licensing arrangement signed in September 2022, GSK obtained global rights with exceptions for Japan and certain Asian countries originally covered by the developer Meiji Seika Pharma’s rights. Spero previously licensed from Meiji. Clinically and commercially, the FDA greenlight matters because it adds a new oral option in a space where IV therapy and hospitalization logistics often drive treatment complexity. Operationally, the approval also underscores how sponsors can reopen stalled regulatory pathways with targeted rework of evidence and endpoints.