August 2026– date –
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Pharmaceuticals and Medical Devices Agency (PMDA) Updates Regenerative Medicine Product Approval List and Advances International Regulatory Harmonization
Pharmaceuticals and Medical Devices Agency (PMDA) Japan Overview On August 5, 2026, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) updated its approval list for regenerative medicine products, covering April 2015 to May 2026. ... -
XellSmart Secures FDA Fast Track Designation for Off-the-Shelf iPSC-Derived Cell Therapy XS411 for Parkinson’s Disease
BioSpace (XellSmart) USA Overview XellSmart announced that its allogeneic, off-the-shelf iPSC-derived cell therapy candidate, XS411, for Parkinson's disease has received Fast Track Designation (FTD) from the U.S. FDA. XS411 aims to repla... -
Washington University-Developed CAR-T Therapy for T-Cell Leukemia and Lymphoma Receives FDA Breakthrough Therapy Designation: Off-the-Shelf Approach Improves Access
Washington University School of Medicine in St. Louis USA Overview A cell-based immunotherapy developed by Washington University School of Medicine in St. Louis, designed to treat rare and aggressive T-cell acute lymphoblastic leukemia a... -
Editas Medicine’s CRISPR Candidate EDIT-401 Achieves Over 90% Reduction in LDL Cholesterol in Non-Human Primates, Suggesting Long-Term Durability for Dyslipidemia
Editas Medicine USA Overview Editas Medicine announced updated preclinical data for EDIT-401, a CRISPR-based investigational drug for dyslipidemia, showing highly promising results. A single dose of EDIT-401 in non-human primate models a... -
FDA Grants Four Regenerative Medicine Advanced Therapy (RMAT) Designations in July: Advancements in Musculoskeletal, Ophthalmic, Oncology, and Neurological Fields
Pharmacally USA Overview In July 2026, the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designations to four distinct investigational drugs, spanning diverse regenerative medicine modalities including cell therapies, ge... -
Promises and Pitfalls of In Vivo CAR Gene Therapy: Clinical Proof-of-Concept Progresses Amidst Focus on Safety and Biological Factors
Blood - ASH Publications USA Overview While ex vivo CAR-T cell therapies demonstrate high efficacy in lymphoid hematologic malignancies, their logistical complexity and high costs limit patient access. In contrast, in vivo CAR gene thera... -
FDA Regenerative Medicine Approvals Accelerate, Outpacing Previous Years with Record Potential for 2026
PharmaLive USA Overview FDA approvals for regenerative medicine products are accelerating significantly, with a record eight approvals in 2024. Approvals between 2023 and 2025 more than doubled the total from 2016-2022. As of July 2026, ... -
CRISPR Gene Editing Therapies Limited to Ex Vivo Approvals for Sickle Cell and Beta-Thalassemia in 2026; In Vivo Candidates Show 87% Attack Reduction and 62% Cholesterol Decrease
DeepDNA USA Overview As of August 2026, the only globally approved CRISPR gene-editing therapies are ex vivo treatments for sickle cell disease and transfusion-dependent beta-thalassemia. However, in vivo therapies are demonstrating sign... -
Fate Therapeutics’ iPSC-Derived CAR-T FT819 Shows Safety and Improved Skin Scores in Refractory Systemic Sclerosis Phase 1; Repligen Acquires BioLife Solutions for $1.5 Billion
DeciBio USA Overview July 2026 highlights in next-generation therapeutics include Fate Therapeutics' preliminary Phase 1 data for FT819, an iPSC-derived CD19-targeted CAR-T cell therapy for treatment-refractory systemic sclerosis, demons... -
Washington University Reports Promising Early Results for Aggressive Blood Cancers with Combined CRISPR Gene Editing and Stem Cell Transplant
The Brighter Side of News USA Overview Researchers at Washington University School of Medicine in St. Louis reported promising early results from a clinical trial combining CRISPR gene editing with stem cell transplantation to treat aggr...
