Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) is one of the 11 Best Short-Term Stocks to Invest in. Amid revenue surges from the existing drugs, Revuforj and Niktimvo in Q2, FDA grants Priority Review ...

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

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.

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

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 ...

FDA prioritizes review of liso-cel, a groundbreaking CAR T-cell therapy for relapsed marginal zone lymphoma, promising ...

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

FDA grants Priority Review for Biologics License Application (BLA) and EMA accepts Marketing Authorisation Application (MAA) for apitegromab as a treatment for spinal muscular atrophy. News release.

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 granted Priority Review to pegcetacoplan for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis ...

“The FDA’s Priority Review designation acceptance of our sBLA reinforces our confidence in WINREVAIR for a broad range of patients and represents a critical step toward advancing the treatment ...