Approvals· September 4, 2026 · 36 min read
Lirafugratinib's Sept 27 PDUFA Does Not Rewrite Pemazyre PAs or Lytgobi CDx
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Topic
Priority Review
Priority review status, shortened FDA review timelines, action-date planning, and launch readiness.
Approvals· September 2, 2026 · 33 min read
Aqneursa's Sept 19 A-T PDUFA Does Not Rewrite NPC-Only PAs or the 15 kg Floor
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Approvals· September 1, 2026 · 29 min read
Camzyos's Sept 30 Adolescent PDUFA Does Not Rewrite Adult REMS or Age-18 PA Gates
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
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
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