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
Topic
Reimbursement
Provider reimbursement, claims processing, ASP/WAC pricing, buy-and-bill economics, and revenue-cycle management for specialty drugs.
Approvals· August 10, 2026 · 14 min read
177Lu-Edotreotide (ITM-11) for GEP-NET: COMPETE Phase 3 Data and Lutathera Access
By Ran Chen#Radiolabeled Therapy#Oncology#FDA Approval
Policy· June 30, 2026 · 17 min read
IRA Medicare Drug Negotiation Proposed Rule: Market-Access Analysis
By Ran Chen#IRA Negotiation#CMS#Market Access
Biosimilars· June 29, 2026 · 18 min read
Soliris Biosimilar Cliff: NMOSD Exclusivity Expiry and Payer Step Edits
By Ran Chen#Biosimilars#Interchangeability#Payer Policy
Pricing & Access· June 24, 2026 · 26 min read
J&J Janssen Portfolio Dossier: Stelara Biosimilars and Oncology Assets
By Ran Chen#Purple Book#Orange Book#Biosimilars
Pricing & Access· June 21, 2026 · 6 min read
Bicillin L-A Shortage: FDA's Lentocilin Importation and Billing Guidance
Generics· June 21, 2026 · 10 min read
Generic Sandostatin LAR Depot: CGT Exclusivity, Supply Shocks, and Buy-and-Bill Economics
By Ran Chen#Generics#Orange Book#HCPCS Coding
Manufacturing· June 13, 2026 · 14 min read
FDA drug shortage list: reading status, reason, and presentation fields
Pricing & Access· June 13, 2026 · 15 min read
NDC lookup for claims teams: reading labeler, product, and package codes before you bill
By Ran Chen#HCPCS Coding#Reimbursement#Pharmacy Benefit
Generics· June 13, 2026 · 17 min read
Orange Book TE codes: how to tell whether a generic can actually be substituted
By Ran Chen#Orange Book#ANDA Approval#Generics