Sanofi's Nexviazyme Meets Primary Goal in Phase 3 Study for Infantile-Onset Pompe Disease
Sanofi's Phase 3 Baby-COMET study showed Nexviazyme improved ventilator-free survival in infants with infantile-onset Pompe disease, supporting plans for a US regulatory filing to expand the therapy's approved indication.
Christopher Corsico | 01/07/2026 | By News Bureau | 111
US FDA Advances Review of Tzield in Young Children
The FDA has accepted Sanofi’s sBLA for Tzield under priority review, seeking broader pediatric use in delaying type 1 diabetes onset.
Christopher Corsico | 06/01/2026 | By News Bureau | 169
Sanofi's Efdoralprin Alfa Meets Key Goals in Phase-II AATD Emphysema Study
Efdoralprin Alfa was previously granted fast track and Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of AATD Emphysema. It is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
Christopher Corsico | 27/10/2025 | By Dineshwori | 499
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