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FDA Shake-Up Sparks Concerns Over Gene Therapy Regulation

6/21/2025

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Summary

Story summary

The FDA faces turbulence after the dismissal of key leaders Nicole Verdun and Rachael Anatol, raising concerns over the regulation of cell and gene therapies. This shake-up comes on the heels of Sarepta's Elevidys approval, which is tied to two tragic patient deaths. Under new director Vinay Prasad, the agency may tighten its oversight, reflecting growing scrutiny.

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Story summary

The FDA faces turbulence after the dismissal of key leaders Nicole Verdun and Rachael Anatol, raising concerns over the regulation of cell and gene therapies. This shake-up comes on the heels of Sarepta's Elevidys approval, which is tied to two tragic patient deaths. Under new director Vinay Prasad, the agency may tighten its oversight, reflecting growing scrutiny.