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
Topic
Cardiovascular
Cardiometabolic and cardiovascular drug access, outcomes evidence, payer policy, and affordability dynamics.
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· July 16, 2026 · 17 min read
Lipfendra (enlicitide) coverage: first oral PCSK9 inhibitor approval
By Ran Chen#Cardiovascular#PCSK9#FDA Approval
Pricing & Access· July 15, 2026 · 18 min read
Heart Failure Access Landscape 2026: GDMT, Entresto Generic, Kerendia, and Verquvo
By Ran Chen#Heart Failure#Payer Criteria#Cardiovascular
Pricing & Access· July 13, 2026 · 20 min read
ATTR-CM Access Landscape: Tafamidis, Acoramidis, and Vutrisiran
By Ran Chen#Rare Disease#Payer Coverage#Payer Criteria
Evidence· July 10, 2026 · 17 min read
Anticoagulant Adverse Events in FAERS: 244,000 Reports and Bleeding/HIT Profiles
Pricing & Access· July 10, 2026 · 21 min read
AstraZeneca Portfolio Dossier: Farxiga Cliff, Enhertu Pivot, and Soliris Conversion
By Ran Chen#Orange Book#Purple Book#Medicare Part D
Evidence· July 8, 2026 · 23 min read
Diuretic Adverse Events in FAERS: 763,000 Reports Across Three Sub-Classes
Evidence· July 8, 2026 · 28 min read
NSAID Adverse Events in FAERS: 1.5 Million Reports and the Non-Aspirin Signal Profile
Pricing & Access· July 7, 2026 · 17 min read
BMS Portfolio Dossier: The Eliquis Cliff, Opdivo Lifecycle, and Cobenfy Bet
By Ran Chen#Orange Book#Purple Book#Medicare Part D