August 2026– date –
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Cell Therapy Clinical Success Hinges on Manufacturability: Limitations of Autologous Therapies Drive Interest in Allogeneic ‘Off-the-Shelf’ Platforms
Cell & Gene Unknown Overview Cell therapy scalability is a critical factor to consider from early development, as autologous therapies face challenges in manufacturing complexity, scheduling constraints, and inherent scalability limitati... -
EVERSANA Selected as Commercialization Partner for Innovacell Inc.’s Novel Cell Therapy ICEF15 for Urgent Fecal Incontinence in the United States
Outsourced Pharma USA Overview EVERSANA has been chosen by Tokyo-based biotechnology firm Innovacell Inc. as its exclusive commercialization partner in the United States. This partnership aims to advance regenerative medicine and cell th... -
China’s First Approved MSC Therapy, Ruibosheng, Launched at Fraction of Global Price, Receives Conditional Approval for Severe GVHD
BioInformant China Overview China's first approved mesenchymal stem cell (MSC) therapy, Ruibosheng, has been launched at a fraction of global pricing, having received conditional approval from the NMPA on January 2, 2025. Approved for st... -
Fate Therapeutics Executives Sell Shares Post-FDA IND Approval for Next-Gen Autoimmune CAR-T Candidate FT839, Market Anticipates Basket Trial Success
TipRanks USA Overview Fate Therapeutics executives engaged in significant insider stock sales following news of the U.S. FDA's Investigational New Drug (IND) approval for FT839, its next-generation off-the-shelf CAR-T candidate for autoi... -
Real-World Data Evaluates Incidence and Management of Cytokine Release Syndrome and Neurotoxicity Following Axicabtagene Ciloleucel or Brexucabtagene Autoleucel CAR-T Cell Therapy Across 87 U.S. Centers
PubMed (Center for International Blood and Marrow Transplant Research) USA Overview The Center for International Blood and Marrow Transplant Research (CIBMTR) conducted a real-world data analysis of 927 B-cell malignancy patients across ... -
FDA Warns Against Unapproved Stem Cell and Exosome Therapies, Approves Products Limited to Specific Blood Disorders
The Bridge Health & Recovery USA Overview The U.S. FDA has publicly warned against clinics marketing stem cell and exosome products with false or unsubstantiated claims. Currently, FDA-approved stem cell-based products are limited, prima... -
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...
