The FDA removed the most severe boxed warnings relating to breast cancer, cardiovascular disease and probable dementia from six menopausal hormone replacement therapies after an agency review and a coordinated industry labeling submission. Commissioner Marty Makary led the push to update labeling to expand access and reduce concern among clinicians and patients. The change follows re‑examination of the Women’s Health Initiative-era data and expert panel input; regulators and industry expect the labeling update to alter prescribing behavior. The decision is likely to trigger broader clinical discussions on benefit‑risk assessment and could increase patient uptake of HRT options previously constrained by the boxed warnings.