Approvals· September 5, 2026 · 29 min read
Topic
Medicare Part D
Part D formulary design, IRA negotiated prices, out-of-pocket caps, LIS/Extra Help, and Medicare drug coverage policy.
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
Policy· August 31, 2026 · 16 min read
CMS Part D 340B Repository: Voluntary Files Do Not Replace Prescriber Math
By Ran Chen#340B#Medicare Part D#IRA Negotiation
Specialty· August 31, 2026 · 36 min read
Generic Erleada (Apalutamide): U.S. Entry, Patents, and Launch Signals
By Ran Chen#Oncology#Generic Entry#Orange Book
Policy· August 20, 2026 · 19 min read
CMS-4215-P Comment Docket: Manufacturers and Hospitals Clash on IRA Rules
By Ran Chen#IRA Negotiation#Policy#Payer Policy
Pricing & Access· August 20, 2026 · 21 min read
Prescription Drug Prices Posted Steepest Drop Since 1963: What CPI Measures
Policy· August 19, 2026 · 18 min read
CMS Bona Fide Marketing Rule: What the D.C. Circuit Teva Ruling Actually Revived
By Ran Chen#Policy#IRA Negotiation#Medicare Part D
Specialty· August 16, 2026 · 17 min read
Leqembi IQLIK Launches: Subcutaneous Lecanemab Moves to Specialty Pharmacy
Policy· August 16, 2026 · 15 min read
Ten PBMs Commit to TrumpRx Cash Prices in Real-Time Tools: The Policy Ledger
By Ran Chen#PBM#Payer Policy#Formulary Strategy
People· August 6, 2026 · 12 min read