INSIGHT: FDA Approves First-Ever RNAi-based Therapy

August 28, 2018

On Aug. 10, 2018, the Food and Drug Administration approved a first-of-its-kind gene therapy product that turns off the expression of an undesired protein using a ‘‘small interfering RNA’’ (siRNA). The approval marks a significant milestone in the story of a Nobel Prizewinning technique, RNA interference (RNAi), and clears the way for a new type of biologic, siRNA.

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