Some gene therapies no longer require clinical trials, thanks to new FDA rule. Is this safe, and who will it help?

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www.livescience.comby https://www.livescience.com/author/kamal-nahasMay 8, 2026Submitted May 11, 2026

The FDA is launching a new framework to deliver tailor-made gene therapies to people with rare genetic disorders. Discussions about whom to treat and how to monitor patients are ongoing.

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