Approvals· September 5, 2026 · 29 min read
Topic
Label Warnings
Boxed warnings, precautions, contraindications, monitoring requirements, and commercial implications of safety language.
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
Approvals· September 3, 2026 · 34 min read
Injectafer's Phosphate Boxed Warning Does Not Rewrite J1439, AP Generics, or Oral-Iron PAs
By Ran Chen#Boxed Warning#Label Warnings#FDA Approval
Approvals· August 23, 2026 · 18 min read
Besremi's August 30 ET PDUFA: Second-Line vs Anagrelide, Not Hydroxyurea
By Ran Chen#PDUFA Date#FDA Approval#Orange Book
Pricing & Access· August 17, 2026 · 25 min read
Tavneos on Formularies as FDA Moves to Withdraw: The Coverage Dilemma
Policy· August 12, 2026 · 38 min read
IARC Group 1 Call on HCTZ, Voriconazole, Tacrolimus: Pharma & P&T Actions
By Ran Chen#FDA#Label Warnings#Formulary Strategy
Specialty· August 9, 2026 · 20 min read
Aesthetic Procedure Adverse Events by the Numbers (2026)
Policy· July 25, 2026 · 28 min read
FDA Boxed Warnings by the Numbers (2026): 1,084 Ingredients, NSAIDs Lead
By Ran Chen#Label Warnings#Boxed Warning#FDA Approval
Evidence· July 14, 2026 · 17 min read
H1 Antihistamines in FAERS: 925,032 Adverse-Event Reports
Evidence· July 13, 2026 · 16 min read