Approvals· September 5, 2026 · 29 min read
Topic
Companion Diagnostic
FDA-approved companion diagnostics, biomarker testing requirements, liquid biopsy, and how diagnostic requirements shape drug access workflows.
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· August 12, 2026 · 39 min read
MK-6240 (Florquinitau F-18) Tau PET: PDUFA, Tauvid, and CMS Coverage Gap
By Ran Chen#FDA Approval#PDUFA Date#Medicare
Pipeline· July 30, 2026 · 19 min read
Companion Diagnostics (2026): FDA PMA Supplement Expansion & Device Landscape
By Ran Chen#Companion Diagnostic#FDA Approval#Oncology
Pipeline· July 22, 2026 · 17 min read
Antibody-Drug Conjugate (ADC) Clinical Trials by the Numbers (2026)
By Ran Chen#ADC#Oncology#Clinical Trials
Policy· July 16, 2026 · 24 min read
Companion diagnostic change control: FDA PMA supplement vs. EU IVDR
By Ran Chen#Companion Diagnostic#FDA Approval#EMA
Approvals· July 16, 2026 · 19 min read
Revtorpyk (gedatolisib) coverage: breast cancer approval and billing
By Ran Chen#Oncology#Breast Cancer#FDA Approval
Specialty· July 7, 2026 · 21 min read
Voranigo (vorasidenib) Glioma Access: Pricing, Biomarker Testing, and Payer PA
By Ran Chen#Oncology#Orphan Drug#Prior Authorization
Pricing & Access· May 31, 2026 · 15 min read
Biomarker documentation mismatch in oncology prior authorization
By Ran Chen#Oncology#Prior Authorization#Payer Policy
Pricing & Access· May 29, 2026 · 10 min read
Tecentriq Hybreza bladder cancer MRD access guide
By Ran Chen#Oncology#PD-L1#Companion Diagnostic