Japan’s regulatory advisory panel recommended conditional approvals for two induced pluripotent stem cell (iPSC) therapies—Amchepry (raguneprocel) and Reheart—under the country’s conditional early approval (CEA) pathway, positioning them as the world’s first iPSC‑derived drugs to receive regulatory clearance. The endorsements follow Japan’s long‑standing regenerative medicine framework and emphasize time‑limited approval pending post‑market data. Separately, cell‑therapy developer iRegene reported dosing milestones: a U.S. Phase IIa Parkinson’s patient received NouvNeu001 and China began randomized enrollment for an MSA (NouvNeu004) trial, underscoring global momentum for off‑the‑shelf iPSC programs. iRegene framed the dual readouts as evidence of scalable, cross‑jurisdiction development. These regulatory and clinical moves signal that Japan’s accelerated path and parallel global programs are enabling earlier patient access for cell therapies, while obligating companies to deliver post‑authorization effectiveness and safety data. Next steps: sponsors will finalize post‑market study requirements, engage payers on conditional coverage, and prepare manufacturing scale‑up for commercial use under time‑limited approvals.