Approvals· August 22, 2026 · 19 min read
Zilganersen's September 22 PDUFA: Alexander Disease ASO & Intrathecal Access
By Ran Chen#FDA Approval#NDA Approval#Priority Review
Topic
Priority Review
Priority review status, shortened FDA review timelines, action-date planning, and launch readiness.
Pipeline· July 1, 2026 · 19 min read
Centanafadine PDUFA July 24, 2026: Pipeline and Access for Otsuka's NDSRI
By Ran Chen#PDUFA Date#Priority Review#CNS and Migraine
Approvals· June 11, 2026 · 10 min read
FDA Commissioner's National Priority Voucher program: what launch teams need to know
Approvals· May 25, 2026 · 8 min read