(Reuters) -British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for ...

US FDA accepts for priority review GSK’s sNDA for gepotidacin for oral treatment of uncomplicated urogenital gonorrhoea: London, UK Tuesday, August 12, 2025, 10:00 Hrs [IST] GSK ...

The NDA for the gonorrhea indication is supported by data from the EAGLE-1 study, which compared the safety and efficacy of oral gepotidacin to a standard of care combination.

GSK (NYSE:GSK) announced on Monday that the U.S. FDA has granted priority review for its marketing application, aimed at ...

GSK plc's experimental antibiotic, gepotidacin, has been granted priority review by the U.S. Food and Drug Administration ...

Gepotidacin was approved by the FDA earlier this year, under the Blujepa brand, as the first oral antibiotic to offer a new ...

GSK (NYSE:GSK) (LON:GSK) said on Monday that the U.S. Food and Drug Administration has accepted its priority review ...

Get comprehensive insights into the Uncomplicated Urinary Tract Infections (UTIs) pipeline with this 2025 report. It details 4+ companies and 5+ pipeline drugs, covering drug profiles, therapeutic ...

By the numbers: UTIs affect up to 16 million women in the U.S. annually, and for 30 to 44% of them, the infection will come ...

Drugmaker GSK moved closer to expanding its antibiotic portfolio on Monday, after US regulators accepted its application to review gepotidacin as a potential oral treatment for gonorrhoea.

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Gepotidacin works by stopping bacteria from multiplying. The U.S. Food and Drug Administration approved the drug in March to treat urinary tract infections in females age 12 and up.