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 ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...

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

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

The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather ...

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

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

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

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...

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

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...