Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug approvals.

The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program.

WASHINGTON (AP) — The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the ...

The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and longtime Stanford University professor, as the director of the Center for ...

The U.S. Food and Drug Administration (FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational gene therapy trials for limb girdle muscular dystrophy following three ...