STAT November 12, 2025
Rather than approving an individual drug, the agency would essentially approve a group to create bespoke therapies
Top Food and Drug Administration officials on Wednesday detailed a roadmap for approving the world’s first personalized gene-editing treatments.
The perspective, published in the New England Journal of Medicine, comes six months after researchers announced they had crafted a custom gene-editing treatment to fix a unique mutation in KJ, an infant born with an ultra-rare,...
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