London: GSK plc has announced that a supplemental New Drug Application for gepotidacin has been accepted by the US Food and ...

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

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

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.

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

A new pill that combats antibiotic-resistant strains of gonorrhoea has inched closer to approval in the US, after the US Food and Drug Administration (FDA) accepted GSK’s gepotidacin for priority ...

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 ...

More than 600,000 cases of gonorrhoea were reported in the U.S. in 2023, according to the U.S. Centers for Disease Control and Prevention. There are no vaccine licenses in the U.S. for preventing the ...

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

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.

GSK (GSK) stock in focus as the company bid to expand use of oral antibiotic agent gepotidacin for urogenital gonorrhea is granted FDA priority review. Read more here.

(Alliance News) - GSK PLC on Monday said its gepotidacin drug has been accepted for priority review in the US as an oral option for the treatment of a form of sexually transmitted infection gonorrhoea ...