High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT ...

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...

Emergency room doctors at three area health systems collected data on patients who had experienced severe withdrawal symptoms ...

The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...

The Food and Drug Administration on Friday approved the first at-home test to screen for cervical cancer, Teal Health, which ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. | GSK had expected to secure an FDA ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

U.S. regulators said Friday that they would allow three new color additives made from natural sources to be used in the ...

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of ...

The U.S. Food and Drug Administration said on Thursday all its centers will deploy artificial intelligence internally ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...