Approvals· September 5, 2026 · 29 min read
Topic
Boxed Warning
Boxed warning label changes, safety restrictions, payer reactions, and commercial implications for prescribing.
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· September 1, 2026 · 29 min read
Camzyos's Sept 30 Adolescent PDUFA Does Not Rewrite Adult REMS or Age-18 PA Gates
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Approvals· August 29, 2026 · 15 min read
Lisraya's DM Label: Boxed-Warning 30 mg Tablet, Table 3 Split, Unapproved 15 mg
By Ran Chen#FDA Approval#JAK Inhibitor#Dermatology
Specialty· August 9, 2026 · 20 min read
Aesthetic Procedure Adverse Events by the Numbers (2026)
Specialty· August 9, 2026 · 17 min read
Alopecia Areata Treatment Access (2026): Litfulo, Leqselvi, and Olumiant
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 13, 2026 · 16 min read
ADHD Medications in FAERS: 194,052 Adverse-Event Reports by the Numbers
Pricing & Access· July 13, 2026 · 17 min read
Duchenne Muscular Dystrophy Access Landscape: Elevidys, Oligonucleotides, and Duvyzat
By Ran Chen#Rare Disease#Gene Therapy#HCPCS Coding
Evidence· July 9, 2026 · 16 min read