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- FDA releases draft guidance to streamline approval of personalized gene therapiesThe FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…
- FDA proposes new rare disease framework to accelerate therapy developmentDuring a public hearing, FDA officials outlined a newly proposed rare disease framework aimed at creating a lasting regulatory scheme. The initiative seeks to speed the development of safe and eff…