The Food and Drug Administration granted Expanded Access Program authorization for NKGen's investigational drug application.

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for deucravacitinib for the treatment of adults with active psoriatic arthritis (PsA).

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner ...

The Food and Drug Administration (FDA) has granted Priority Review to TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s top drug regulator, the agency confirmed Monday.

SHELTON, CT / ACCESS Newswire / July 21, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.: NNVC ) (the ...

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

Oruka Therapeutics Inc (NASDAQ:ORKA) saw its stock rise 6.6% after revealing that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application to begin a ...

An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

Icotrokinra is a first-in-class targeted oral peptide that blocks interleukin (IL) 23 and its receptor, which plays a key role in the inflammatory response in plaque psoriasis.

Lurbinectedin plus atezolizumab significantly reduced the risk of disease progression or death by 46% compared with atezolizumab alone.