References
The 2025–2026 FDA label change
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- U.S. Department of Health and Human Services; U.S. Food and Drug Administration. HHS advances women's health, removes misleading FDA warnings on hormone replacement therapy [news release]. Silver Spring, MD: FDA; 10 November 2025.Verified Announcement that the FDA would initiate removal of the boxed warnings, following a scientific literature review, a July 2025 expert panel and a public comment period.
- U.S. Food and Drug Administration. FDA approves labeling changes to menopausal hormone therapy products [news release]. Silver Spring, MD: FDA; 12 February 2026.Verified Approval of the first six revised labels, removing the cardiovascular disease, breast cancer and probable dementia statements from the boxed warning; 29 manufacturers had submitted proposed changes. The endometrial cancer boxed warning on systemic estrogen-alone products remains.
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