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.

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 ...

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?

Priority review is granted to medicines that meet all of the following requirements. In addition, medicines designated as orphan drugs and pioneering medicines will be given priority for review.