British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...

The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...

A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...

Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.

The U.S. Food and Drug Administration announced a massive recall of 30 different kinds of produce over possible contamination ...

Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...

The U.S. Food and Drug Administration declined to approve Capricor Therapeutics' cell therapy for a heart condition and asked ...

One San Francisco-based company aims to find a sustainable alternative by creating plant-based salmon, and with its recent ...

FDA Commissioner Dr. Marty Makary joins ‘Fox & Friends’ co-host Steve Doocy for a morning walk to discuss the agency’s focus ...

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...