iPSC– tag –
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FDA Issues Draft Guidance to Streamline Regulatory Submissions for Cell and Gene Therapy Products by Leveraging Prior Knowledge
Pharmuni USA Overview The U.S. FDA has released new draft guidance aimed at accelerating the development of cell and gene therapy products for rare diseases. This guidance permits developers to leverage existing scientific, manufacturing... -
Stem Cell Therapies for Parkinson’s Disease Advance to Clinical Stages: BlueRock’s Phase 3 and Japanese iPSC Program Lead the Way
NeurologyLive USA Overview Stem cell therapies for Parkinson's Disease, particularly dopamine cell replacement trials, are making significant strides into advanced clinical stages. BlueRock Therapeutics' embryonic stem cell (ESC)-derived... -
Century Therapeutics’ iPSC-Derived Type 1 Diabetes Therapy CNTY-813 Demonstrates Durable Glucose Control and Immune Evasion in Preclinical Studies
BioSpace (Century Therapeutics) USA Overview Century Therapeutics announced groundbreaking preclinical data for its iPSC-derived islet replacement therapy, CNTY-813, designed for Type 1 Diabetes (T1D) with Allo-Evasion™ 5.0 technology, a... -
Fate Therapeutics Presents Positive Clinical and Preclinical Data for iPSC-Derived Off-the-Shelf CAR T Therapies FT819, FT839, and FT836 in Autoimmune Diseases and Solid Tumors
Fate Therapeutics USA Overview Fate Therapeutics unveiled updated clinical and preclinical data for its iPSC-derived off-the-shelf CAR T-cell programs at EULAR and in corporate presentations. The Phase 1 trial for anti-CD19 CAR T-cell th... -
Japan Reinforces LMO Safety Regulations for Advanced Biotech Research and Regenerative Medicine
厚生労働省 Japan Overview Japan's Ministry of Health, Labour and Welfare (MHLW) has reissued critical guidelines on the contained use (Type 2) of living modified organisms (LMOs) under the Cartagena Act. This re-notification emphasizes s... -
BlueRock Therapeutics Initiates Patient Enrollment for Parkinson’s Disease iPSC-Derived Cell Therapy exPDite-2 Phase 3 Trial; Long-Term Follow-Up Data Imminent
Neurology Live USA Overview BlueRock Therapeutics has initiated patient enrollment for its Phase 3 exPDite-2 clinical trial, transplanting iPSC-derived dopaminergic neurons in Parkinson's disease patients. The trial will involve approxim... -
Fujifilm Reshuffles Life Sciences Leadership and Opens New Facility to Quadruple iPSC Manufacturing Capacity
FUJIFILM Holdings America Corporation Press Release USA Overview FUJIFILM Holdings America Corporation announced a reshuffle in the leadership of its life sciences group, with Delara Motlagh appointed as President and COO of FUJIFILM Cel... -
Avaí Bio Achieves GMP Milestone for Anti-Aging Cell Therapy; Beam Therapeutics Targets Accelerated Approval for BEAM-302; Sana Partners with Mayo Clinic for Type 1 Diabetes
Newswire.ca Canada Overview Multiple biotech companies reported significant advancements: Avaí Bio completed its GMP-grade Master Cell Bank (MCB) for the α-Klotho anti-aging program, paving the way for preclinical and clinical trials. Be... -
Made Scientific and Pluristyx Announce Integrated iPSC Development & Manufacturing Partnership to Accelerate Next-Generation iPSC-Derived Cell Therapies
PR Newswire USA Overview Made Scientific, a cell therapy CDMO, and Pluristyx, an iPSC platform technology provider, announced an integrated iPSC development and manufacturing partnership. This collaboration aims to accelerate the clinica... -
Fate Therapeutics Presents FT819/FT839 Data at EULAR 2026: Rapid, Sustained Improvement and Favorable Safety Profile in SLE Patients
GlobeNewswire (Fate Therapeutics Press Release) USA Overview Fate Therapeutics presented data from its off-the-shelf CAR T-cell programs, FT819 and FT839, at the 2026 European Congress of Rheumatology (EULAR) Annual Meeting. FT819 demons...
