FDA Lifts Black Box Warning on Hormone Therapy, Resetting a Two-Decade Regulatory Framework
SHERIDAN, WYOMING - November 13, 2025 - In a sweeping regulatory shift with major implications for women's health providers, pharmaceutical manufacturers, and payers, the FDA has removed the black box warning from all hormone replacement therapy (HRT) products. The reversal ends a 22-year stance shaped by the early 2000s Women's Health Initiative (WHI) trial and opens the door to renewed clinical adoption and investment across the growing HRT market.