Japan Grants World-First Approvals for iPS Cell–Based Therapies in Heart Failure and Parkinson’s

Japan approved two therapies derived from reprogrammed human iPS cells for heart failure and Parkinson’s disease, marking the first global use of iPS-derived cells in approved medical products. The treatments—one applied to the heart surface and the other injected into the brain—entered conditional, time-limited use requiring ongoing safety and effectiveness data after launch, reflecting Japan’s specialized regulatory and manufacturing infrastructure and the ongoing influence of Shinya Yamanaka in the field.