Approvals· September 5, 2026 · 29 min read
Section
Approvals
FDA decisions, label language, review pathways, and what approvals imply for access and launch sequencing.
45 articles · Last updated
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· September 2, 2026 · 33 min read
Aqneursa's Sept 19 A-T PDUFA Does Not Rewrite NPC-Only PAs or the 15 kg Floor
By Ran Chen#PDUFA Date#FDA Approval#NDA 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 31, 2026 · 18 min read
Stelara's Pediatric UC License Does Not Write Wezlana Pediatric IBD Substitution
By Ran Chen#Biosimilars#Interchangeability#Purple Book
Approvals· August 30, 2026 · 16 min read
Mounjaro's CV Claim Is Noninferiority vs Trulicity, Not Placebo Superiority
By Ran Chen#GLP-1#GIP/GLP-1#Diabetes and Obesity
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
Approvals· August 29, 2026 · 24 min read
Mimrylo for PV Erythrocytosis: 76.9% Week 20-32 Response and Platelet Rises
By Ran Chen#FDA Approval#Hematology#Coverage Access
Approvals· August 29, 2026 · 17 min read
Rasonque's Pancreatic Label Needs No RAS Test: 2L Data Does Not Write 1L Access
By Ran Chen#FDA Approval#Oncology#Coverage Access