The U.S. Food and Drug Administration announced steps to remove longstanding boxed warnings from hormone replacement therapy (HRT) products used for menopause, concluding prior label language overstated certain risks. Agency officials, including Commissioner Marty Makary, said evidence supports narrowing the warnings to better reflect current data on cardiovascular and cancer risk. HHS and FDA officials signaled they will work with manufacturers to update labeling without an advisory committee process. The move follows reanalysis of long‑term trial results and aims to expand access to HRT for symptomatic women while cautioning clinicians to balance benefits and individualized risk. The regulatory change will shift clinical practice, payer policies, and patient counseling. Companies that market HRT products will need to submit labeling amendments; clinicians and patient advocates expect rapid uptake but warned the messaging must avoid overpromising benefits.