accepts

The US Food and Drug Administration has accepted for Priority Review a supplemental biologic license application for Tzield (teplizumab-mzwv) to expand its age indication to include children as young as …

The FDA has accepted for priority review a supplemental biologics license application (sBLA) for teplizumab-mzwv (Tzield; Sanofi) that seeks to expand the current age indication from 8 years and older …