The U.S. Food and Drug Administration has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for all approved CAR-T cell therapies, including those from Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson, and Novartis. This regulatory shift acknowledges the accumulated clinical experience in managing the therapies' key toxicities — cytokine release syndrome and neurotoxicity — and is set to broaden patient access by lowering administration barriers and facility restrictions. The FDA now considers the therapies safe and effective without the earlier certification demands. The move reflects evolving understanding and confidence in CAR-T management protocols within hematology and oncology communities.