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
GI and Liver
IBD, liver disease, specialty-drug access, evidence, and payer criteria across gastroenterology.
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
Pricing & Access· May 27, 2026 · 7 min read