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

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

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 ...

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

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

GSK (NYSE:GSK) announced Monday that the U.S. Food and Drug Administration has accepted its priority review application for ...

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 ...

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 ...

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 ...

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