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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 [...]
FDA Eases Access To Life-Saving Gene Therapies For Blood Cancers
The U.S. Food and Drug Administration (FDA) announced on Friday that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies. These products are gene therapies currently…
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