Stephanie S. Faubion, MD, on choosing between fezolinetant and elinzanetant, liver monitoring, follow-up, and open questions in menopause care.
News|Articles|July 4, 2025
Key FDA approvals in women’s health: First half of 2025
Author(s)Morgan Ebert
Fact checked by: Celeste Krewson, Assistant Editor
A roundup of the most impactful FDA approvals in women’s health from January through June 2025, spanning diagnostics, therapeutics, and at-home care.
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The first half of 2025 has brought several pivotal FDA approvals that are expanding access to care, advancing diagnostic accuracy, and addressing long-standing gaps in women’s health.
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JoAnn V. Pinkerton, MD, MSCP, reviews 4 pooled elinzanetant analyses from OASIS presented at The Menopause Society Annual Meeting 2026, spanning late perimenopause, sleep, VMS reduction, and safety.
The FDA approved the first generic of Climara Pro, a weekly estradiol/levonorgestrel patch for VMS and osteoporosis prevention in women with a uterus.
In September, the FDA accepted an extended duration sNDA for the IUD with a decision expected in Q2 2027.
Pritelivir healed all HSV lesions by day 28 in 63% of immunocompromised adults vs 34% with comparators.
Menopausal brain fog is common, and hormone therapy has neutral cognitive effects, according to Pauline M. Maki, PhD.
NK receptor antagonists significantly improved sleep disturbance in menopausal women at 4, 12, and 24 weeks in a meta-analysis of RCTs.
Perimenopausal women who were more physically active had significantly lower symptom burden across all domains, a study of 1808 Flo app users found.
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