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

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

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 ...

US FDA accepts for priority review GSK’s sNDA for gepotidacin for oral treatment of uncomplicated urogenital gonorrhoea: London, UK Tuesday, August 12, 2025, 10:00 Hrs [IST] GSK ...

In the U.S., a rare disease is defined as one that affects fewer than 200,000 people. This status allows for priority review, fast track status and breakthrough therapy designation.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema ...

For " priority reviews," a designation available for drugs offering significant improvements in safety or effectiveness for serious conditions, the performance goal is 6 months.