The FDA removed the most severe 'black box' warnings related to breast cancer, cardiovascular disease and dementia from labeling for six hormone replacement therapies used in menopause. Commissioner Marty Makary led the labeling change after an agency review and input from industry, experts and manufacturers. Twenty‑nine companies submitted proposed label revisions at the FDA's request; the agency convened expert panels and reviewed the broader literature, concluding that prior warnings were discouraging access. The label changes are meant to help clinicians and patients make informed decisions about HRT use for symptomatic relief. The move is likely to affect prescribing patterns and payer coverage for menopausal therapies and signals a willingness by the agency to reevaluate long‑standing safety statements in light of evolving evidence.