Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) is one of the 11 Best Short-Term Stocks to Invest in. Amid revenue surges from the ...

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

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

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

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

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 ...

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

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 ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower drug costs. Could it work?

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.