Dr. Marty Makary, the FDA’s commissioner, said the company is asking the agency to approve “a new product” based on old data. Novavax’s shot uses traditional protein-based vaccine ...

I can't comment on any particular application. As you know, we have a bunch of applications for those booster shots," FDA Commissioner Dr. Marty Makary told CBS News chief Washington correspondent ...

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...

The FDA issued a public alert on Tuesday concerning generic versions of a widely-used hair loss drug that is frequently distributed by popular telehealth brands like Hims and Keeps. The agency ...

The FDA made the announcement in statement about "an aggressive timeline to scale use of artificial intelligence internally across all FDA centers by June 30, 2025, following the completion of a ...

The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind.

The U.S. Food & Drug Administration (FDA) has announced the approval of three natural-source colors in food items. Galdieria extract blue, butterfly pea flower extract and calcium phosphate can ...

Now it’s begging them to come back. Senior FDA officials asked laid-off employees in recent days to temporarily return after mass cuts decimated the agency’s ability to penalize retailers that ...

The FDA updated a recall of tuna products sold at popular stores like Walmart, Kroger, Costco and Trader Joe’s that may be contaminated with a rare bacteria that can cause paralysis or death.

The FDA said Tuesday that the review -- part of its "Operation Stork Speed" initiative -- will look at whether current nutrient requirements need to be updated, including whether additional ...

Former Food and Drug Administration (FDA) Commissioner Robert Califf said the federal agency that he’s known for years “is finished” after mass layoffs began Tuesday morning. “The FDA as ...

The FDA has suspended its food testing lab quality control program due to staffing cuts. Staffing cuts at HHS agencies, including the FDA, have occurred since Robert F. Kennedy Jr.'s confirmation ...