Specialty· September 12, 2026 · 21 min read
Specialty Pharmacy Transfers: What Happens to a Pending Prior Authorization?
By Ran Chen#Specialty Pharmacy#Prior Authorization
Topic
Specialty Pharmacy
Limited distribution, hub services, fulfillment routing, REMS friction, and payer-channel coordination.
Approvals· September 5, 2026 · 29 min read
Etcamah's Sept 4 Approval Does Not Rewrite Orserdu PAs or ODAC's ctDNA Dispute
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 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
Specialty· August 30, 2026 · 23 min read
Libre Duo's Dual Glucose-Ketone De Novo Is Not a Medicare CGM Coverage Decision
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
Approvals· August 27, 2026 · 18 min read
Tivicay PD's Neonatal Expansion: Term, 2 kg Floor; Tablets Do Not Substitute
By Ran Chen#FDA Approval#HIV#Infectious Disease