Vinay Prasad, director of the Center for Biologics Evaluation and Research, will leave the FDA at the end of April, an agency ...

Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...

Scientific, political pressures colliding at FDA, delaying rare disease treatment for patients who have few or no options, experts said at CNBC Cures Summit.

Below is a review of novel drug and biological products approved by the Food and Drug Administration (FDA) in 2025. The list includes several groundbreaking therapies that are expected to change the ...