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

Members of an FDA expert panel discussed reassessing boxed warnings for menopausal HT and how to better educate patients and ...

A panel of 12 experts in the menopause field reexamined the findings of the 2002 Women’s Health Initiative study that said ...

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

While Astellas’ Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved for menopause, Lynkuet is the first ...

A first-of-its-kind solution for women’s arousal - the same active ingredient as in Viagra® for men - in a proprietary topical formulation demonstrated to work where women need it most SAN DIEGO, July ...

Interim Phase 3 Results Support Ovaprene's Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly ContraceptiveSAN DIEG ...

Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today ...

Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today ...

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.

The FDA has granted priority review to an application for Revuforj for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia.

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, the agency is investigating two Duchenne muscular dystrophy patient ...