FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
U.S. Food and Drug Administration
CONFIRMED84% CONFIDENCEThe FDA[1][4] news release is headed "For Immediate Release: February 12, 2026" and says the FDA "has approved drug labeling changes to six menopausal hormone therapy products".
The FDA approves new labels for six menopausal hormone therapy products, one from each class, that drop the cardiovascular, breast cancer and dementia statements from the boxed warning; 29 companies have filed changes.
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