Pricing & Access· September 10, 2026 · 23 min read
Topic
Clinical Evidence
Trial design, endpoints, real-world evidence, safety updates, and how evidence translates into market access.
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
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
Evidence· August 29, 2026 · 23 min read
Treatment-Regimen Estimands in FDA Labels: Answering the Real Coverage Question
By Ran Chen#Clinical Evidence#Clinical Trials#FDA
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
Policy· August 24, 2026 · 18 min read
FDA's Expedited IND Pilot: 30-Day Safe-to-Proceed Clock and QRI Review
By Ran Chen#FDA Approval#Clinical Evidence#Pipeline