iPSC– tag –
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iRegene Therapeutics’ NouvNeu001 Secures Dual FDA Expedited Designations: A New Regulatory Milestone for iPSC Therapies
RegMedNet UK Overview iRegene Therapeutics announced its allogeneic iPSC-derived therapy, NouvNeu001, received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for Parkinson's disease, following its prior Fast ... -
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... -
Vertex’s Zimislecel Cell Therapy Achieves Insulin Independence in 10 of 12 Type 1 Diabetes Patients
Breakthrough T1D Australia Overview Vertex Pharmaceuticals announced highly promising results from its FORWARD-101 trial of Zimislecel (formerly VX-880), an iPSC-derived cell therapy for Type 1 Diabetes (T1D). Ten of 12 participants achi... -
iPSC Clinical Trials Deliver Breakthroughs: Parkinson’s, Heart Failure, Cancer Immunotherapies Show Promising Results
Americord Registry USA Overview Induced pluripotent stem cell (iPSC) research is rapidly transforming medicine, with multiple clinical trials reporting significant progress across diverse disease areas. A Kyoto University Hospital trial ... -
FUJIFILM Cellular Dynamics Quadruples iPSC Manufacturing Capacity with New Madison Facility
FUJIFILM Cellular Dynamics USA Overview FUJIFILM Cellular Dynamics (FCDI) has inaugurated a new headquarters and iPSC development and manufacturing facility in Madison, Wisconsin. This strategic expansion quadruples FCDI's capacity for p... -
XellSmart Initiates Phase II Trial for iPSC-Based Parkinson’s Therapy Following Encouraging Phase I Results
The Regen Report USA Overview XellSmart has advanced its iPSC-derived cellular therapy for Parkinson's disease into Phase II clinical trials, driven by positive safety and preliminary efficacy data from its Phase I study. This critical p... -
Cell-Easy Launches Large-Scale iPSC-Derived Beta Cell Program to Address Manufacturing Bottlenecks for Diabetes Therapy
BioInformant USA Overview Cell-Easy has initiated a new program focused on scaling up the manufacturing of iPSC-derived beta cells, addressing a critical bottleneck for diabetes therapies. This initiative aims to establish a stable, high... -
Americord Registry Spotlights Latest Breakthroughs in iPSC Clinical Trials Across Diverse Disease Areas
Americord Registry USA Overview Americord Registry has released a comprehensive report detailing the latest advancements in iPSC clinical trials, highlighting expanding applications in neurological and ophthalmic conditions. The report i... -
K Pharma Advances Diverse Pipeline: Six iPSC-Based Drug Discovery Programs and Five Regenerative Medicine Projects in Progress
Kabutan.jp Japan Overview K Pharma's Q1 financial report reveals steady progress across its iPSC-based drug discovery and regenerative medicine divisions. The company is actively developing six pipelines in drug discovery and five pipeli...
