The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) for approved CAR-T therapies targeting BCMA and CD19 antigens, streamlining safety monitoring protocols established since 2017. This regulatory change applies to treatments from Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson, and Novartis, reflecting accumulated clinical experience in managing cytokine release syndrome and neurological toxicities. Concurrently, the FDA is investigating Sarepta’s Duchenne therapy following reported patient deaths, and scrutiny surrounds KalVista’s rare disease drug review, marking a period of significant regulatory shifts impacting biotherapeutics.