The U.S. Food and Drug Administration announced it will work with manufacturers to remove boxed warnings on hormone replacement therapies (HRTs) used for menopause, concluding that the historical risks had been overstated. The agency’s decision follows reviews of long-term data and is intended to expand access to menopausal symptom management. Officials and some clinicians warned the change may increase appropriate use while also cautioning against overselling benefits for conditions beyond symptomatic relief. The regulator emphasized updated labeling will focus on evidence-based risk information. Manufacturers now face label-change submissions and clinicians can expect revised guidance on HRT prescribing; payers and patient groups will monitor whether the regulatory shift changes utilization patterns for hormone therapies.