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

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

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

The growing number of fatalities is raising questions about the future of Sarepta’s therapies and the regulatory path for ...

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped to a new 52-week low on Friday, triggering a trading halt after Bloomberg ...

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

An Food and Drug Administration expert panel on Thursday endorsed removing the "black box" warning on hormone treatments for ...

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...

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

US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels ...

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

“Now, by expanding the palette of available colors derived from natural sources, food manufacturers have a variety of options ...