July 2026– date –
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FDA RMAT Designations Hit Record 48 in 2025, Signaling CGT Pipeline Maturity and Market Acceleration
Pharmaceutical Technology UK Overview FDA Regenerative Medicine Advanced Therapy (RMAT) designations surged from 2024, reaching a record 48 in 2025, according to Pharmaceutical Technology analysis. This unprecedented increase reflects th... -
China Grants World’s First Solid Tumor CAR-T Approval for Satri-cel in Advanced Gastric Adenocarcinoma
Fierce Biotech USA Overview China's National Medical Products Administration (NMPA) has approved CARsgen Therapeutics' solid tumor CAR-T cell therapy, satri-cel, for HER2-negative, Claudin18.2-positive advanced gastric and gastroesophage... -
USC Scientists Engineer ‘Endless Supply’ of iPSC-Derived Immune Cell Precursors to Supercharge Cancer Immunotherapy
ScienceDaily (University of Southern California) USA Overview University of Southern California (USC) scientists have successfully cultured a virtually limitless supply of immune cell precursors, inspired by induced pluripotent stem cell... -
FDA RMAT Designations Reach 162 Total: Rocket Pharmaceuticals and CRISPR Therapeutics Lead
BioInformant USA Overview The FDA's publicly announced Regenerative Medicine Advanced Therapy (RMAT) designations have reached a total of 162, with approximately half of all RMAT applications being approved, according to BioInformant dat... -
FDA Approves Allogeneic Cell Therapy TREGZI for GVHD; New Advanced Cell Therapy Association Launches in Europe
RegMedNet UK Overview The FDA has approved Orca Bio's allogeneic cell therapy TREGZI (Orc-T®) for graft-versus-host disease (GVHD), based on positive Phase 3 Precision-T trial results, aiming to mitigate GVHD and reconstruct immunity. Si... -
HCA Healthcare Announces Promising Results for CRISPR Gene Therapy Exa-cel in Pediatric Sickle Cell Disease and Beta-Thalassemia Patients
HCA Healthcare USA Overview HCA Healthcare has announced findings from a New England Journal of Medicine study, sponsored by Vertex Pharmaceuticals, demonstrating that the CRISPR gene-editing therapy exa-cel shows promising results in pe... -
CRISPR’s First Clinical Evidence for HBV cccDNA Elimination, Prime Editing Advances to Inaugural Human Trial
CRISPR Medicine News USA Overview Precision Biosciences' PBGENE-HBV has demonstrated the first clinical evidence of eliminating viral cccDNA in chronic Hepatitis B patients, marking a significant milestone for CRISPR-based therapies in i... -
3D Bioprinted Organoids Pave the Way for Clinical Translation in Oncology, Regenerative Medicine, and Drug Discovery
Reproductive Biology (Oxford Academic) UK Overview 3D bioprinted organoids are demonstrating significant advances in oncology, regenerative medicine, and drug discovery by more faithfully replicating in vivo tissue structures and functio... -
Continuous Manufacturing and Automated Closed Systems Revolutionize Cell & Gene Therapy Production for Enhanced Efficiency and Quality
News-Medical.net UK Overview The commercial manufacturing of cell and gene therapies is being transformed by the imperative for continuous processing and automated closed systems to overcome current scalability and quality challenges. Th... -
BioNetwork Consulting Introduces Agentic AI for Clinical Operations, Offering Expertise in Gen AI Governance and Real-World Evidence Strategy
BioNetwork Consulting USA Overview BioNetwork Consulting now offers specialized expertise in integrating Agentic AI into Clinical Operations, with a strong focus on Generative AI (Gen AI) Governance & Regulatory Compliance, and Real-...
