Elevidys Gene Therapy Under Stricter FDA Controls After Fatal Liver Injury Reports
1. Background on Elevidys 2. Trigger for Regulatory Action 3. Nature of the FDA Action (Labeling & Indication Revision) On November 14, 2025, the FDA approved revised labeling for Elevidys. Key components: 3.1 Boxed Warning 3.2 Indication Limitation 3.3 Updates to Other Labeling Sections 3.4 Monitoring and Risk-Mitigation Measures The revised labeling mandates specific monitoring […]