Troy– Author –
-
Fayuvi: FDA approval and specs for MPS IIIA gene therapy in 2026
CGTlive® USA Overview The FDA has granted approval to rebisufligene etisparvovec-hopf (Fayuvi), the first gene therapy for pediatric Sanfilippo Syndrome Type A (MPS IIIA). Fayuvi is a one-time intravenous AAV9 gene therapy designed to de... -
Evotec: iPSC-derived CAR γδ T-cell manufacturing specs for 2026
News-Medical.Net Germany Overview Evotec has established a scalable, xeno-free bioprocess platform for developing immune-evasive and tumor microenvironment (TME)-resistant iPSC-derived CAR γδ T-cells (CAR iγδ T-cells) targeting hepatocel... -
Anito-cel: Phase 1 trial specs and 100% response rate for CAR-T
EurekAlert! (via Mass General Brigham) USA Overview In a Phase 1 clinical trial led by Mass General Brigham Cancer Institute and the University of Chicago Medicine Comprehensive Cancer Center, the BCMA-targeted CAR-T cell therapy, anitoc... -
Made Scientific: 85,000 sq-ft cell therapy facility acquisition
Contract Pharma USA Overview Made Scientific has acquired an 85,000 square-foot cell therapy manufacturing facility in East Norriton, Pennsylvania, from National Resilience. The facility, designed for clinical development through commerc... -
FDA vs EMA: CGT manufacturing and potency assay requirements
Rhizome AI USA Overview Significant structural differences exist between FDA and EMA manufacturing controls and GMP requirements for Cell and Gene Therapy (CGT) at the IND/CTA stage. The FDA maintains more explicit early-stage requiremen... -
Ryoncil: Mesoblast’s new FDA potency assay specs for GVHD drug
Mugglehead Australia Overview Mesoblast has received FDA approval for a new potency assay, the T-cell Proliferation Inhibition BioAssay (TIBA), for Ryoncil (remestemcel-L), its treatment for pediatric steroid-refractory acute Graft-versu... -
iPSC Cell Therapy: 2026 roadmap for BeiGene, BlueRock and Fate
BioInformant USA Overview As of 2026, leading companies such as BeiGene, BlueRock Therapeutics, and Fate Therapeutics are actively advancing diverse pipelines of iPSC-derived cell therapeutics. Notably, Fate Therapeutics has secured FDA ... -
NVIDIA Isaac ROS 5.0: FoundationPose 5.5x speedup explained
NVIDIA Technical Blog USA Overview NVIDIA has released Isaac ROS 5.0, enhancing the ability of robot developers to build agent-enabled open-source robotics applications. The new version features "FoundationPose," a foundational model tha... -
ISM001-055: Phase 2a clinical trial specs for TNIK inhibitor
Brieflands USA Overview The small molecule TNIK inhibitor rentosertib (formerly ISM001-055/INS018_055), discovered and designed using a generative AI approach, is being evaluated in a randomized Phase 2a clinical trial for idiopathic pul... -
Stanford Biotech: 37,000 AI agents’ drug discovery roadmap
Stanford Medicine USA Overview An AI-powered virtual biotech company, spun out of a Stanford Medicine lab, is deploying 37,000 AI agents across the entire drug discovery pipeline, dramatically accelerating the prediction of high-potentia...
