The U.S. FDA revised the label for Sarepta’s Duchenne gene therapy Elevidys, adding a boxed safety warning and narrowing its use to ambulatory patients while requesting postmarketing study commitments. The agency’s labeling action reflects closer scrutiny of safety profiles for in‑vivo gene therapies and signals higher regulatory conditionality for complex biologics. Separately, the Association for Molecular Pathology (AMP) released draft guidelines for interpreting and reporting cancer sequencing variants, including recommendations on reporting therapeutic biomarkers, liquid biopsy results, and mutational signatures (TMB, MSI, HRD). The draft aims to harmonize reporting standards across clinical NGS labs and to clarify how genomic signatures should inform therapy selection and trial enrollment.