Approvals· August 21, 2026 · 19 min read
Pasatru's FOP Approval: What Garetosmab's $1.4M Launch Means vs Sohonos
By Ran Chen#FDA Approval#BLA Approval#Rare Disease
Topic
BLA Approval
Biologics License Application approval strategy, labeling, manufacturing, exclusivity, and launch implications.
Biosimilars· June 10, 2026 · 8 min read
Biosimilar competition decoded: 229 products across 20 reference drugs, one concentration
By Ran Chen#Biosimilars#Purple Book#Formulary Strategy
Pipeline· June 8, 2026 · 11 min read
Botulinum toxin biosimilar pathway: the 351(k) race to challenge Botox
By Ran Chen#Biosimilars#FDA Approval#BLA Approval
Approvals· June 8, 2026 · 9 min read
FDA drug-device combination product pathway: PMOA and launch strategy
Pipeline· June 5, 2026 · 11 min read
Atacicept PDUFA preview: first dual BAFF/APRIL therapy approaches IgA nephropathy decision
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Approvals· May 25, 2026 · 8 min read