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

One of the most significant biomedical achievements of the 21st century, mRNA vaccines have reshaped the world’s ability to ...

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

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 ...

GSK (NYSE:GSK) announced on Monday that the U.S. FDA has granted priority review for its marketing application, aimed at ...

A new pill that combats antibiotic-resistant strains of gonorrhoea is closer to US approval, after the FDA accepted GSK’s gepotidacin for priority review.

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