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Japan Approves World’s First iPSC-Derived Therapies ‘ReHeart’ for Heart Failure and ‘Amchepry’ for Parkinson’s Disease
Science Today Japan Overview Japan has granted the world's first approvals for groundbreaking induced pluripotent stem cell (iPSC)-derived therapies: 'ReHeart' for heart failure and 'Amchepry' for Parkinson's disease. These treatments ai... -
IPS HEART’s iPSC-Derived Cell Therapy ISX9-CPC Secures FDA Rare Pediatric Disease Designation, Advancing Clinical Trials for Cardiac & Rare Muscle Disorders
Facebook (IPS Heart) USA Overview IPS HEART announced that its iPSC-derived cell therapy, ISX9-CPC, received Rare Pediatric Disease Designation (RPDD) from the FDA. Targeting cardiac and rare muscle disorders, this designation positions ... -
PMDA’s 2026 Strategy: Streamlining Approvals for Next-Gen Regenerative Medicine, Including iPSCs
独立行政法人 医薬品医療機器総合機構 (PMDA) Japan Overview Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has detailed its 2026 operational strategy for approving novel pharmaceuticals, medical devices, and regenerative medicin... -
Pioneering Pluripotency: Japan Approves World’s First iPSC-Derived Therapies for Heart Failure and Parkinson’s
再生医療 みなとみらい麻の葉クリニック Japan Overview In a historic global first, Japan's Ministry of Health, Labour and Welfare has granted conditional and time-limited approval to two induced pluripotent stem cell (iPSC)-derived regener... -
Japan Approves Pricing for World’s First iPSC-Derived Product, Amchepry, Signaling New Era for Regenerative Medicine
薬事日報 Japan Overview Japan's Central Social Insurance Medical Council has approved the official drug pricing for three new regenerative medicine products, including Sumitomo Pharma's iPSC-derived dopamine neural progenitor cells, Amch...
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