Nxera’s Vamorolone Granted Key Regulatory Designations Supporting Faster Access for Duchenne Muscular Dystrophy Patients in South Korea

Orphan Drug Designation (ODD) recognizes Duchenne muscular dystrophy as a rare disease with significant unmet medical need without an established treatment in South Korea.Global Innovative Products on Fast Track (GIFT) designation, a priority review pathway introduced by Korea's Ministry of Food and Drug Safety, may support accelerated regulatory review and faster patient access to innovative therapies in South Korea.Nxera plans to submit a Marketing Authorization Application for vamorolone in S