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.
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FDA Eases Access To Life-Saving Gene Therapies For Blood Cancers - Johnson & Johnson (NYSE:JNJ), Novartis (NYSE:NVS), Gilead Sciences (NASDAQ:GILD), Bristol-Myers Squibb (NYSE:BMY)
FDA lifts REMS for approved CAR-T therapies, easing hospital restrictions and signaling broader future access in oncology and autoimmune treatment.
FDA drops REMS requirement for some CAR-T therapies – RamaOnHealthcare
The FDA has eliminated Risk Evaluation and Mitigation Strategies for all currently approved BCMA- and CD19-directed autologous CAR-T cell immunotherapies, determining that the safety program is no longer necessary to ensure the benefits of the therapies outweigh the risks. The FDA said existing clinical experience and improved understanding of managing severe side effects, such as [...]
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