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.

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

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

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

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

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

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 ...

Gepotidacin works by stopping bacteria from multiplying. The U.S. Food and Drug Administration approved the drug in March to treat urinary tract infections in females age 12 and up.

The development of Blujepa (gepotidacin) has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response ...

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 ...

Results from GSK's EAGLE-1 phase 3 trial on gepotidacin, an oral antibiotic for uncomplicated urogenital gonorrhea. Non-inferior to leading treatment, it offers a potential solution amid rising ...

Gepotidacin, a first-in-class investigational oral antibiotic, is efficacious against uncomplicated urinary tract infections (UTIs) in adolescent and adult women and noninferior to nitrofurantoin ...