In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

The FDA has scuttled Merus’ plans to win a speedy approval for i | The FDA has scuttled Merus’ plans to win a speedy approval ...

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims ...

there are 64 oncology drug indications on the US market with accelerated approvals only. The FDA estimates the accelerated ...

At the center of this fight is how the FDA regulates a possible "functional cure" for Type 1 diabetes and determines who gets ...

RFK Jr., a longtime anti-vaccine activist, to play a role in Trump administration and potentially influence how the FDA and ...

Election Day is just about here, marking an end to the unpredictable ride that has been the 2024 presidential race following ...

Acute kidney injury is being redefined as a collection of syndromes, each of which could be targeted by specific biomarkers.

However, there are some situations in which the regulatory process is considered ... potential impact on approvals of the FDA's authority to require REMS (Nature Rev. Drug Discov.

President-elect Trump’s promise to let Robert F. Kennedy Jr. “go wild” on health is demoralizing public health experts, who ...