US FDA updates Sanofi’s Dupixent label for atopic dermatitis
This label update is based on findings from the Phase III LIBERTY-AD-HAFT trial, the first to evaluate a biologic for this patient group. Dupixent, a fully human monoclonal
Sanofi has received approval from the US Food and Drug Administration (FDA) for a supplemental biologic licence application for Tzield (teplizumab-mzwv), allowing its use to delay stage 3 type 1 diabetes (T1D) onset in children as young as one year diagnosed with stage 2 T1D.
This agreement focuses on treating fourth-line gastrointestinal stromal tumours (GIST) in adult patients. The territories covered under the deal include Croatia, Bulgaria, Czech Republic, Cyprus, Greece, Estonia, Latvia,