Once confined to the realm of theoretical science fiction, cell and gene therapies (CGTs) have crossed decisively into clinical and commercial reality. In less than a decade, the world has witnessed landmark approvals, from the first CAR-T cell therapies for blood cancers to gene therapies restoring vision in patients with inherited retinal dystrophies, and most recently, gene-editing platforms that offer potentially curative single-dose interventions for conditions like sickle cell disease. Regulators have been keeping pace: the FDA and EMA together have approved over 30 CGT products, with the annual approval cadence accelerating from one or two per year in the early...
