FDA crosses a regulatory watershed with personalized neoantigen cancer vaccine, per Gottlieb
alex_peys · x · 2026-10-23
Former FDA commissioner Scott Gottlieb calls it a watershed for FDA regulation: every patient on the vaccine arm received a different product, with neoantigens chosen from sequencing of each person's own tumor—so FDA had no single active sequence to review, relying instead on an IND that pre-specified how the product would change per patient. The poster frames this personalized-medicine milestone as far more consequential than agent bots.
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