The FDA is reconsidering the black box warning on estrogen. Experts say it’s time for a change—find out what this means for ...

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

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

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

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 ...

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

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

Sarepta's cost-saving moves, FDA surprises, and pipeline potential position SRPT as a unique opportunity. Read here for an ...

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

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

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

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