Following through on efforts initiated in November 2025, the U.S. FDA approved drug labeling changes for six menopausal hormone replacement therapies (HRTs) that removes the risk statements related to cardiovascular disease, breast cancer and probable dementia from the boxed warnings.

More than a decade after it was first proposed, the U.S. Precision Medicine Initiative that grew into the NIH’s All of Us dataset has reached its target of collecting genetic and health-related data from 1 million Americans representative of the diversity across the country.

After two decades of work with Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy, PTC Therapeutics Inc. withdrew its bid for approval of the compound upon hearing from the U.S. FDA. Regulators told Warren, N.J.-based PTC that the data package for Translarna is “unlikely to meet the agency's threshold of substantial evidence of effectiveness.”