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FDA Loosens Restrictions on First-Gen CAR-T Therapies

UNITED STATES, JUN 30 – The FDA aims to ease provider burden and expand patient access by removing REMS for CAR T therapies, while continuing long-term safety monitoring for up to 15 years, officials said.

Summary by Pharmaphorum
There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.

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MyChesCo broke the news in on Sunday, June 29, 2025.
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