Approvals· July 3, 2026 · 17 min read
Icotyde (icotrokinra) FDA approval and oral IL-23 psoriasis access
By Ran Chen#FDA Approval#Dermatology#Immunology
Section
Approvals
FDA decisions, label language, review pathways, and what approvals imply for access and launch sequencing.
18 articles · Last updated
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
Approvals· June 30, 2026 · 18 min read
Utebzi (tebipenem pivoxil) FDA Approval: Stewardship & Launch Access
Approvals· June 11, 2026 · 10 min read
FDA Commissioner's National Priority Voucher program: what launch teams need to know
Approvals· June 10, 2026 · 10 min read
The FDA approval engine: 29,135 applications, 78% generics, and a BLA surge
By Ran Chen#FDA Approval#Generic Entry#Biosimilars
Approvals· June 10, 2026 · 10 min read
What the EU approves: 2,313 medicines, 29% oncology, 28 biosimilars in 2024
Approvals· June 8, 2026 · 9 min read
FDA drug-device combination product pathway: PMOA and launch strategy
Approvals· June 7, 2026 · 8 min read
Imfinzi + BCG for NMIBC access guide: FDA approval, coding, and buy-and-bill
By Ran Chen#Oncology#PD-L1#Prior Authorization