Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...

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

A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...

( NewsNation) — The head of the U.S. Food and Drug Administration signaled Thursday that he supports changing or removing the ...

US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk.

Health Secretary Robert F. Kennedy Jr. and other Trump officials are signaling their interest in approving psychedelic drugs ...

The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

During a press conference on Monday, Food and Drug Administration Commissioner Marty Makary spoke about the agency's ...

Dr. Marty Makary, FDA commissioner, joins 'Squawk Box' to discuss what hindsight tells science about the best route to take ...