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基因编辑治疗公司因简化FDA审批流程而崛起

2025-11-01 00:14

  • Companies focused on gene editing therapies, including CRISPR Therapeutics (CRSP), Editas Medicines (EDIT), and Intellia Therapeutics (NTLA) are trading higher Friday following a report that the US FDA will make it easier for these medicines to gain approval.
  • In an interview with Bloomberg, Vinay Prasad, director of the agency's Center for Biologics and Research, said, "Regulation has to evolve as fast as science evolves," adding the FDA is "going to be extremely flexible and work very fast with the scientists who want to bring these therapies to kids who need it."
  • Prasad intends to outline in early November how a streamlined pathway for gene editing therapy approvals would work, adding that the paper will serve to boost investment in the gene editing space.
  • A separate paper published Friday in The American Journal of Human Genetics on how clinical trials can be conducted so that a single trial of several genetic disorders can be conducted rather than separate ones for each condition.

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