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The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...
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 (NYSE:GSK) announced on Monday that the U.S. FDA has granted priority review for its marketing application, aimed at ...
The FDA has accepted GSK's application for priority review of gepotidacin, a first-in-class antibiotic for uncomplicated ...
GSK (NYSE:GSK) announced Monday that the U.S. Food and Drug Administration has accepted its priority review application for ...
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 ...
British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority ...
Gepotidacin was approved by the FDA earlier this year, under the Blujepa brand, as the first oral antibiotic to offer a new ...
GSK (NYSE:GSK) (LON:GSK) said on Monday that the U.S. Food and Drug Administration has accepted its priority review ...
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 ...