The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...

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

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

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 ...

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 ...

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 ...

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

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.

PHILADELPHIA, March 25, 2025--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg ...