The FDA accepted an sNDA and granted priority review for elinzanetant to treat VMS in women receiving endocrine therapy to treat or prevent HR+ breast cancer.
News|Articles|October 1, 2026
A recap of top FDA & regulatory news from September 2026
Author(s)Joshua Fitch, Senior Editor
Fact checked by: Benjamin P. Saylor
A recap of Contemporary OB/GYN's top FDA and regulatory news from September 2026.
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September brought a strong slate of FDA and regulatory developments across women’s health, from a supply update on a widely used menopause therapy to a priority review designation for a non-hormonal VMS treatment. Below, the Contemporary OB/GYN team recaps the top FDA-related stories from the month.
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The FDA office of Women's Health and Center for Drug Evaluation and Research and hosting a public workshop with a focus on testosterone use in menopausal women.
FDA accepted for review an sNDA for MIUDELLA copper IUD for a 6-year duration, with a PDUFA date in Q2 2027.
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Fezolinetant was linked to VMS and sleep improvements by week 4 in the real-world OPTION-VMS study, presented at the International Menopause Society World Congress.
Wen Shen, MD, highlights perimenopause as an important period for identifying health risks and supporting healthy aging beyond the menopausal transition.
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