Cell Therapy News
Cell therapy is one of the fastest-growing areas in modern medicine, with breakthroughs happening across research, clinical trials, and regulatory approvals. This page brings you a curated selection of the most important news shaping the future of cell therapy drug development. From scientific advances to key updates from regulatory agencies, we make it easy to stay informed on the developments that matter most.
The FDA released three new draft guidances to streamline cell and gene therapy development. The documents outline innovative trial designs for small populations, expedited pathways for serious conditions, and improved postapproval methods for monitoring long-term safety and efficacy...
Avance Biosciences is excited to exhibit at the ASGCT 2025 conference in New Orleans, LA, from May 13–17, 2025. Join us to explore our expert bioanalytical solutions for gene and cell therapy development. Visit booth #750 to learn how we can support your therapeutic advancements...
A new study offers hope for improving CAR-T cell therapy in treating B-cell Acute Lymphoblastic Leukemia (B-ALL), a cancer with high relapse rates. Researchers have developed an innovative approach involving a TIM-3 decoy that prevents immune evasion by leukemia cells...
Tecelra is the first FDA-approved T cell receptor (TCR) gene therapy. The product is an autologous T cell immunotherapy composed of a patient’s own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma...
Two hallmark toxicities of chimeric antigen receptor (CAR) T-cell therapy may be rare after 2 weeks following infusion in patients with diffuse large B-cell lymphoma (DLBCL), supporting a shorter, more flexible toxicity monitoring period, according to a recent study...
Avance Biosciences™ is excited to announce our participation in the American Society of Gene & Cell Therapy (ASGCT) conference, where we’ll be showcasing our advanced services and expertise to propel the future of gene and cell therapy. [...]
CAR T-cell therapies show promise for blood cancers but struggle with solid tumors due to T-cell weakness in tumor microenvironments. Researchers find genetic alterations in cancerous T cells, giving engineered T cells "superpowers" to effectively kill tumors without behaving like cancer cells...
In this draft guidance, the FDA emphasizes that potency assays and their corresponding acceptance criteria should be designed to make meaningful contributions to potency assurance by reducing risks to product potency. They provide illustrative examples of approaches to potency assay development that are...
We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated Cell & Gene Therapy Manufacturing Conference, and we cordially invite you to join us! As a leader in advanced therapies, we understand the importance of staying at the forefront of cell and gene therapy innovation...
Specifically, the guidance recommends conducting analytical comparability studies to provide scientific evidence of the impact that manufacturing changes may have on the safety, potency, and purity of human cellular and gene therapy products...