FDA should judge drugs on what they do in real life, not just in companies’ clinical trials by Aaron Kheriaty, opinion contributor - 07/08/25 7:00 AM ET AP Photo/Elise Amendola, file ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

The FDA has approved Moderna’s next-generation COVID-19 vaccine for people older than 65. REUTERS “The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect ...

While the administration's goal is to replace petroleum-based dyes with natural alternatives in the U.S. food supply, the FDA has stopped short of an outright ban.

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 ...

HHS Secretary Robert F. Kennedy Jr. asked the FDA "to review the latest data on mifepristone ," but experts say concerns about the abortion pill's safety are misguided.

The U.S. Food and Drug Administration (FDA) approved a new, twice-yearly shot — the first and only of its kind — to prevent HIV, the creator of the drug, Gilead Sciences, announced on Wednesday.

WASHINGTON (AP) — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional ...

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.

In a statement, FDA Commissioner Martin Makary said 10% of people aged 65 and older have Alzheimer's. "I am hopeful that new medical products such as this one will help patients," Makary said. The ...

The FDA is revoking or proposing to revoke 52 food standards (such as canned fruits, dairy, and baked goods), citing that they’re outdated and not aligned with current consumer needs or food ...

FDA warns of severe itching risk when stopping long-term use of allergy medications cetirizine and levocetirizine, affecting quality of life for some users.