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

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

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

The integration of AI into drug submission and approval processes signifies a shift towards more efficient pharmaceutical ...

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...

The FDA announced marketing authorization of a form of light therapy as the first-ever treatment for dry age-related macular ...

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

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

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

The FDA estimates the accelerated process gets drugs to patients with cancer about 3 years faster than if initial approvals ...

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