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
Topic
PDUFA Date
FDA action-date calendars, review milestones, launch readiness, and what teams should monitor before decisions.
Pipeline· June 8, 2026 · 11 min read
Botulinum toxin biosimilar pathway: the 351(k) race to challenge Botox
By Ran Chen#Biosimilars#FDA Approval#BLA Approval
Pipeline· June 7, 2026 · 9 min read
Cytisinicline smoking cessation PDUFA preview: first new pharmacotherapy in 20 years
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Pipeline· June 5, 2026 · 11 min read
Atacicept PDUFA preview: first dual BAFF/APRIL therapy approaches IgA nephropathy decision
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Pipeline· June 5, 2026 · 12 min read
Gedatolisib PDUFA preview: pan-PI3K/mTOR inhibitor targets HR+/HER2– breast cancer gap
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Pipeline· June 3, 2026 · 9 min read
Cendakimab PDUFA preview: IL-13 inhibitor for eosinophilic esophagitis
By Ran Chen#PDUFA Date#FDA Approval#Immunology
Pipeline· June 3, 2026 · 10 min read
NASP PDUFA preview: anti-drug antibody strategy for uncontrolled gout
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Pipeline· June 2, 2026 · 10 min read
Orca-T allogeneic cell therapy PDUFA preview: access implications for AML, ALL, and MDS
By Ran Chen#PDUFA Date#FDA Approval#Hematology
Pipeline· May 31, 2026 · 10 min read
Olezarsen Tryngolza sNDA preview for severe hypertriglyceridemia
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Pipeline· May 31, 2026 · 8 min read
Tebipenem HBr PDUFA preview for oral carbapenem access
By Ran Chen#PDUFA Date#FDA Approval#Infectious Disease