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

Additionally, the FDA has granted a Priority Review for Revuforj’s supplemental New Drug Application (sNDA) in relapsed or ...

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the ...

GSK (NYSE:GSK) (LON:GSK) said on Monday that the U.S. Food and Drug Administration has accepted its priority review ...

Gepotidacin was approved by the FDA earlier this year, under the Blujepa brand, as the first oral antibiotic to offer a new ...

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.

There’s a new twist in the fight against bladder cancer — and it’s delivering game-changing results. In a recent clinical ...

A new pill that combats antibiotic-resistant strains of gonorrhoea has inched closer to approval in the US, after the US Food and Drug Administration (FDA) accepted GSK’s gepotidacin 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, ...