Approvals· September 5, 2026 · 29 min read
Topic
Pivotal Trials
Registrational studies, trial design, primary endpoints, comparator choices, and evidence packages behind approvals.
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 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
Pipeline· August 19, 2026 · 20 min read
Avexitide LUCIDITY Phase 3: What the First GLP-1 Antagonist Means for PBH Access
By Ran Chen#Pipeline#GLP-1#Clinical Evidence
Pipeline· August 19, 2026 · 16 min read
INTerpath-001 Phase 3: Intismeran Autogene and Keytruda's Post-2028 Strategy
By Ran Chen#Pipeline#Clinical Evidence#Pivotal Trials
Pipeline· July 26, 2026 · 18 min read
Alzheimer's Disease Clinical Trials by the Numbers: 2026 Registry Analysis
Pipeline· July 2, 2026 · 17 min read
The Anti-Obesity Phase 3 Pipeline: Active Trials and Mechanisms
By Ran Chen#GLP-1#Weight Loss#Clinical Evidence
Approvals· July 2, 2026 · 18 min read
Lifyorli (Relacorilant) FDA Approval and Ovarian Cancer Access
By Ran Chen#FDA Approval#Pivotal Trials#Payer Criteria