Hormone therapy has endured a rather bumpy history after the Women’s Health Initiative published clinical trial data in 2002 ...

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

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

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

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

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

Sarepta Therapeutics shares surged 34% in after-hours trading on Wednesday after the company said it would slash 500 jobs, or ...

Black box warnings, also known as boxed warnings, are the most stringent warnings the FDA can mandate for prescription drugs, alerting healthcare providers and patients to serious or life ...

New data shows no increased cardiovascular risk of the osteoporosis drug vs anabolic agents — and even suggests a lower risk.

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

Black box warnings — the most serious label the Food and Drug Administration (FDA) places on a drug — are designed to notify consumers and physicians of serious safety risks linked to a medication, ...

The U.S. Food and Drug Administration (FDA) has issued its most serious warning -- a black-box warning -- for Veozah, a medication used to relieve hot flashes in menopausal women, due to rare but ...