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US FDA approves GSK's oral antibiotic for drug-resistant UTIs

A staff member walks down stairs in the main lobby of GSK offices in London, Britain, February 20, 2025. REUTERS/Chris J. Ratcliffe
A staff member walks down stairs in the main lobby of GSK offices in London, Britain, February 20, 2025. REUTERS/Chris J. Ratcliffe Reuters

The U.S. FDA has approved GSK's oral antibiotic to treat complicated urinary tract infections, the regulator said on Wednesday, giving patients a new treatment option against drug-resistant infections.

The approval of the oral antibiotic, branded as Utebzi, offers a more convenient way to treat complicated infections-including a type of kidney inflammation called pyelonephritis-at home instead of in a hospital.

While simple UTIs respond well to outpatient antibiotics, complicated UTIs carry a higher risk of treatment failure and can sometimes be fatal. Complicated UTIs affect more than 2.8 million people in the United States each year.

GSK said the drug is expected to be available to U.S. patients by the end of 2026.

(Reporting by Sriparna Roy in Bengaluru and Bhanvi Satija in London; Editing by Tasim Zahid)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published June 17, 2026 at 8:16 AM.

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