FDA Signals Higher Efficacy Bar for New CAR‑T Cancer Therapies

FDA; CAR-T; chimeric antigen receptor T-cell therapy; oncology; regulatory standards; superiority trials; randomized controlled trials; overall survival; hematologic malignancies; cell and gene therapy

Meeting on the Mesa 2025 Arrives Amid Mixed Signals for Cell and Gene Therapy Sector

Cell and gene therapy; Meeting on the Mesa; Commercialization; Clinical trials; Advanced therapies; Industry partnerships; Regulatory challenges; Phoenix Arizona; mRNA; Gene editing; Alternative payment models