The regulatory environment continues evolving, with the FDA implementing significant changes affecting drug approvals and monitoring. Notably, the FDA has eased safety restrictions on CAR-T therapies, as detailed previously. Additionally, the agency extended impurity data submission deadlines for nitrosamine concerns and issued new draft guidance clarifying remote regulatory assessments without mandatory post-assessment reports. These moves reflect a trend toward adaptive regulatory practices aimed at balancing patient safety with innovation facilitation. In Europe, biotech leaders are advocating for legislative incentives to boost cell and gene therapy development as part of the upcoming Biotech Act.