iPS Cells & Regenerative Medicine– category –
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FDA Finalizes Flexible CMC Framework for Cell and Gene Therapy Approvals, Accelerating Personalized Medicine Regulatory Pathways
BioProcess International USA Overview The U.S. FDA finalized a flexible Chemistry, Manufacturing, and Controls (CMC) framework for cell and gene therapy (CGT) product approvals, releasing a guidance document on May 5, 2026. This framewor... -
CREATE Medicines Expands Targeted In Vivo CAR Platform via Monash University Partnership, Driving Cell-Type-Specific Delivery with Advanced LNP Technology
BioSpace Australia Overview CREATE Medicines has expanded its targeted in vivo CAR platform through a strategic research collaboration and exclusive license agreement with Monash University. This partnership leverages targeted lipid nano... -
FDA Approves Tregzi, First Regulatory T-Cell (Treg) Immunotherapy for Chronic GVHD Prevention, Expands Casgevy Indication to Pediatric Patients
Cell and Gene Therapy Catapult USA Overview On June 30, 2026, the U.S. FDA approved Tregzi, the first regulatory T-cell (Treg)-based immunotherapy designed to prevent chronic graft-versus-host disease (GVHD) and improve survival. Tregzi ... -
CAR-T Cell Therapy for Multiple Myeloma: Real-World Data Validates Enduring Efficacy with 33% Five-Year Progression-Free Survival
Liv Hospital Turkey Overview Real-world data on CAR-T cell therapy for multiple myeloma reveals 33% of patients remained progression-free for five years after a single infusion. This robust evidence also showed an encouraging 66% progres... -
Aspen Neuroscience’s ANPD001 Cell Therapy for Parkinson’s Disease Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation, Signaling Accelerated Development
RegMedNet USA Overview A RegMedNet report indicates that Aspen Neuroscience's ANPD001 cell therapy for Parkinson's disease has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA, based on preliminary Pha... -
Liv Hospital Accelerates iPSC Therapy with Bioreactor Investment, Targeting Parkinson’s Disease
Liv Hospital Turkey Overview Liv Hospital is addressing the critical challenge of safe and efficient mass production of induced pluripotent stem cells (iPSCs) through a major investment in advanced bioreactor systems. This initiative aim... -
IPS HEART’s iPSC-Derived Cell Therapy ISX9-CPC Receives FDA Rare Pediatric Disease Designation for Muscular Dystrophy-Associated Cardiomyopathy
StreetInsider USA Overview IPS HEART, Inc. announced that its iPSC-derived cell replacement therapy, ISX9-CPC, has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for cardiomyopathy associated with muscular dystrophi... -
Porton Advanced Secures China NMPA Commercial Manufacturing License for CGT Products, Expanding CDMO Services from Process Development to Commercialization
Contract Pharma China Overview Porton Advanced has obtained a Class C drug manufacturing license from China's National Medical Products Administration (NMPA), enabling it to provide commercial contract manufacturing services for cell and... -
AI and 3D Bioprinting Transform Regenerative Medicine: Companies like BioLattice Accelerate Organ Manufacturing with Real-Time Quality Control and Optimized Bioinks
Ahead of the Herd Unknown Overview The convergence of artificial intelligence (AI) and 3D bioprinting is accelerating the manufacturing of organs and tissues in regenerative medicine. AI significantly enhances 3D bioprinting accuracy and... -
Resilience and Eli Lilly Expand Strategic Partnership with $750M Investment to Boost U.S. Manufactured Medicine Supply
Resilience USA Overview Resilience and Eli Lilly and Company have expanded their strategic partnership with a significant $750 million investment aimed at increasing the supply of critical medicines manufactured in the U.S. This investme...
