News

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 ...
The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...
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 (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 ...
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.
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 ...
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 ...
British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority ...
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, ...
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 ...