FDA officials and outside auditors have closely studied how long the agency takes to complete its oversight work, as it has struggled to cut down on a backlog of foreign inspections and complaints ...

FDA approves Moderna’s next-generation COVID vaccine for adults 65 or older By . Reuters. Published May 31, 2025, 5:19 a.m. ET. The US Food and Drug Administration has approved Moderna’s next- ...

What to know about the effort to get rid of artificial food dyes 04:06. The U.S. Food and Drug Administration announced Friday it has approved the use of three color additives from natural sources ...

FDA to issue new vaccine approval guidance amid questions over coronavirus shots. FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming ...

FDA staffers who spoke with Stat news, meanwhile, called the tool "rushed" and said its capabilities were overinflated by officials, including Makary and those at the Department of Government ...

In its Friday approval letter, the FDA didn’t explain the restrictions although they reflect skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials ...

The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk. The authorization was confirmed by digital health tech company ...

The agency is recommending slashing the sleeping pill dosage in half for women. Jan. 10, 2013— -- The manufacturers of Ambien, Ambien CR, Zolpimist, Edluar, and other sleeping medications ...

We're now closer to being able to diagnose the most common form of dementia with a simple test. The Food and Drug Administration on May 16 said it cleared the first blood test for Alzheimer's disease.

The FDA picked the LP.8.1 Covid strain for the fall vaccines, fueling concerns that the shots may be limited to only the most at-risk Americans this fall.