August 2026– date –
-
FDA Issues Draft Guidance for Long-Term Follow-Up of Gene Therapies, Establishing Industry Standards for Safety and Efficacy
STAT News USA Overview The U.S. Food and Drug Administration (FDA) has released new draft guidance for the long-term safety and efficacy follow-up of approved gene therapy products. This guidance aims to establish industry standards for ... -
BioPharma Dive Features Real-World Evidence Analysis of Approved CAR-T Therapies, Unveiling New Insights into Subgroup Efficacy and Long-Term Safety
BioPharma Dive USA Overview BioPharma Dive published an in-depth analysis of post-market real-world data for approved CAR-T cell therapies. The article reveals novel insights into efficacy within specific patient subgroups and the long-t... -
Company Announces Positive Safety and Early Efficacy Signals in Phase 1 Clinical Trial of iPSC-Derived Retinal Cell Therapy, Aims for Phase 2 This Year
Endpoints News USA Overview A cell therapy development company has reported favorable safety data and initial efficacy signals from its ongoing Phase 1 clinical trial of an iPSC-derived cell therapy for a specific ocular disease. This th... -
Major Pharmaceutical Company Forges Strategic Alliance with Gene-Editing Biotech to Accelerate Multi-Disease In Vivo Gene Editing Therapy Development
Fierce Biotech USA Overview A leading pharmaceutical company announced a strategic partnership with a biotech firm specializing in gene-editing technology. This alliance aims for the co-development of in vivo gene-editing therapies acros... -
Stealth Cell Therapy Startup Secures Series B, Accelerating iPSC-Derived Neurodegenerative Candidate Towards IND
Specialized Media / Company Announcement USA Overview An undisclosed cell therapy startup has successfully closed its Series B funding round, securing substantial capital. This investment will accelerate preclinical development and suppo... -
WuXi Advanced Therapies Significantly Expands Cell Therapy Manufacturing Capacity to Meet Surging Client Demand, Reinforcing GMP Capabilities and Process Development
WuXi Advanced Therapies China Overview WuXi Advanced Therapies announced a substantial expansion of its cell therapy manufacturing facilities. This significant investment aims to address the growing demand from clients for complex cell t... -
Hitachi Drives Industrialization of Cell Therapies with AI-Powered Manufacturing Innovation
Hitachi Japan Overview Hitachi has initiated a new collaboration with prominent research institutions to advance innovative cell processing technologies. This partnership is designed to significantly enhance the efficiency and scalabilit... -
Lonza Reports Robust Cell and Gene Therapy Sector Growth in H1 2026 Earnings, Driven by CDMO Contracts and Facility Utilization
Lonza Switzerland Overview Lonza announced strong growth in its cell and gene therapy division in the first half of 2026 earnings, propelled by an increase in new CDMO contracts and improved utilization of existing manufacturing faciliti... -
Catalent Enhances End-to-End Cell and Gene Therapy Services to Accelerate Market Entry of Novel Therapeutics
Catalent USA Overview Catalent has significantly bolstered its comprehensive, end-to-end service portfolio in the cell and gene therapy sector. This enhancement aims to accelerate the market entry of client therapies by providing seamles... -
Thermo Fisher Scientific Dramatically Expands Global Cell and Gene Therapy CDMO Manufacturing Capacity with Enhanced Automation
Thermo Fisher Scientific USA Overview Thermo Fisher Scientific has significantly expanded its global manufacturing network for cell and gene therapy products to meet surging demand. This strategic move aims to provide advanced manufactur...
