Experts worry the warning on vaginal estrogen menopause treatments is doing more harm than good and is not supported by science.

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

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm ...

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

Sarepta's gene therapy pipeline faces renewed scrutiny after a third patient death and FDA plans for a black box warning on ...

On Thursday in Washington, D.C., the U.S. Food and Drug Administration (FDA) convened a panel of top experts to reassess the ...

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...

( NewsNation) — The head of the U.S. Food and Drug Administration signaled Thursday that he supports changing or removing the warnings printed on hormone replacement therapy products for menopausal ...

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

The FDA is reevaluating longtime warnings on hormone replacement therapy products for menopausal women. Some advocates for ...

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