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 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 ...

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

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 ...

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 ...

(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 ...

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.

OPEN The FTSE 100 was expected to open just 5.8 points higher ahead of the bell after wrapping up the previous session 0.6% lower at 9,095.73.

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

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.

One near-term rival is Johnson & Johnson's FcRn inhibitor nipocalimab, which started a phase 3 programme last December.