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 ...

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 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- ...

The FDA was on track to grant full approval for the vaccine April 1, according to two people familiar with the matter who spoke on the condition of anonymity to share internal deliberations.

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 ...

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 ...

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 FDA recommends that women currently prescribed higher doses should continue taking their medications, but consult with their healthcare provider about cutting their dosage in half to reduce ...

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.