Approvals· July 3, 2026 · 17 min read
Icotyde (icotrokinra) FDA approval and oral IL-23 psoriasis access
By Ran Chen#FDA Approval#Dermatology#Immunology
Topic
FDA Approval
NDA, BLA, ANDA, 505(b)(2), label language, review packages, and approval-pathway interpretation.
Approvals· July 3, 2026 · 17 min read
Lynavoy (linerixibat) FDA approval: first IBAT inhibitor for PBC pruritus
By Ran Chen#FDA Approval#GI and Liver#Rare Disease
Approvals· July 3, 2026 · 17 min read
Yuviwel (navepegritide) FDA approval and once-weekly achondroplasia access
Approvals· July 2, 2026 · 18 min read
Lifyorli (Relacorilant) FDA Approval and Ovarian Cancer Access
By Ran Chen#FDA Approval#Pivotal Trials#Payer Criteria
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
Policy· June 30, 2026 · 18 min read
China Drug Trial Data Protection (NMPA 2026 No.47): Exclusivity and BD Strategy
By Ran Chen#China#NMPA#Regulatory
Policy· June 30, 2026 · 18 min read
FDA Market Exclusivity by the Numbers: Exclusivity and GAIN Registry Analysis
By Ran Chen#Orange Book#Generics#Generic Entry
Approvals· June 30, 2026 · 18 min read
Utebzi (tebipenem pivoxil) FDA Approval: Stewardship & Launch Access
Policy· June 28, 2026 · 19 min read
How to Read an FDA REMS: ETASU, Shared vs. Single REMS, and the Patent Dance
By Ran Chen#REMS#Generics#FDA Approval
Generics· June 27, 2026 · 18 min read
Generic Aubagio Market: ANDA Litigation Settlements and NADAC Pricing
By Ran Chen#Generics#FDA Approval#Market Access