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
Topic
REMS
Risk Evaluation and Mitigation Strategies, restricted distribution, certification, monitoring, and access friction.
Policy· August 14, 2026 · 18 min read
FDA AEMS Explained: FAERS Replacement, Dashboard, & Safety Pipelines
By Ran Chen#Policy#FDA Approval#Clinical Evidence
Approvals· August 7, 2026 · 14 min read
Iberdomide FDA PDUFA review: first-in-class CELMoD for multiple myeloma
By Ran Chen#FDA Approval#Multiple Myeloma#Oncology
Deals· August 5, 2026 · 19 min read
Lilly's $3.8B AtaiBeckley deal: big pharma validates psychedelics for TRD
By Ran Chen#M&A#Eli Lilly#Psychedelic Therapy
Specialty· August 4, 2026 · 13 min read
Narcolepsy & Idiopathic Hypersomnia Access: Wakefulness to Oxybates
By Ran Chen#Specialty Pharmacy#REMS#Prior Authorization
Policy· July 15, 2026 · 22 min read
The Post-CREATES REMS Moat Map: Safety Programs Shielding Brands After the Fix
By Ran Chen#REMS#Biosimilars#Generic Entry
Evidence· June 29, 2026 · 19 min read
Opioid Analgesics FAERS Adverse Events and REMS: 2021–2026 Trends
Policy· June 28, 2026 · 19 min read
How to Read an FDA REMS: ETASU, Shared vs. Single REMS, and the Patent Dance
By Ran Chen#REMS#Generics#FDA Approval
Generics· June 26, 2026 · 22 min read
Generic Revlimid REMS Launch: Lenalidomide ANDA Entry and NADAC Absence
By Ran Chen#Generics#Orange Book#Oncology
Biosimilars· June 21, 2026 · 6 min read