The FDA has accepted GSK’s application for priority review of gepotidacin, a first-in-class antibiotic for uncomplicated ...

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

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.

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

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 ...

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 ...

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.

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 ...

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 ...