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- FDA drafts guidance to speed approvals of individualized gene therapies, hailed as win for rare disease patientsThe U.S. Food and Drug Administration released draft guidance aimed at streamlining the approval process for certain individualized gene therapies. The proposal would allow sponsors to avoid filing…
- FDA releases draft guidance to streamline approval of personalized gene therapiesThe FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease.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…