The US Food and Drug Administration (FDA) broke new ground last week when it authorized the world’s first human clinical trial for an in vivo genome editing application. The investigational new drug (IND) application approval for California-based Sangamo, which is the first and only company to put a gene editing therapy into clinical trials, allows the company to begin conducting in 2016 a Phase 1/2 open-label, dose-escalation study in up to nine male adults with severe hemophilia B. (Regulatory Focus, Regulatory Affairs Professionals Society)