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

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

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

"GSK’s oral antibiotic for gonorrhoea set for FDA review" was originally created and published by Pharmaceutical Technology, ...

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.

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 ...

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 ...

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

On Thursday, GSK said the study testing gepotidacin for gonorrhea was ongoing and had not yet progressed to the same stage as the UTI trial. (The-CNN-Wire & 2022 Cable News Network, Inc., a Time ...

Wendy Cheng, PhD, MPH, discusses how the study on the efficacy of gepotidacin vs nitrofurantoin in a nitrofurantoin-resistant population (a pooled analysis of the EAGLE-2 and EAGLE-3 trials) aimed ...

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 ...