Europe moved to close the gap left by an FDA rejection of Sanofi’s multiple sclerosis therapy tolebrutinib. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) provided backing for a subset of MS patients, setting up a potential path to approval despite Sanofi’s complete response letter in December. The EU decision matters because it indicates regulators may accept a narrower, biomarker- or phenotype-defined population even after FDA declined the overall approach. For MS drug developers, the outcome also reinforces how label segmentation and evidence-framing can drive regulatory outcomes across jurisdictions. Separately, Regeneron’s hearing loss gene therapy Otarmeni (lunsotogene parvec) cleared the U.S. FDA, becoming the first gene therapy approved under the agency’s National Priority Voucher program. The approval covers congenital hearing loss caused by otoferlin (OTOF) variants, and Regeneron said it will offer the treatment at no cost to eligible U.S. patients.