Approvals· September 5, 2026 · 29 min read
Topic
FDA Approval
NDA, BLA, ANDA, 505(b)(2), label language, review packages, and approval-pathway interpretation.
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
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
Approvals· September 2, 2026 · 33 min read
Aqneursa's Sept 19 A-T PDUFA Does Not Rewrite NPC-Only PAs or the 15 kg Floor
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
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
Policy· August 31, 2026 · 18 min read
CMS RAPID Is an IDE Presubmission NCD Clock, Not Post-Authorization Coverage
Approvals· August 31, 2026 · 18 min read
Stelara's Pediatric UC License Does Not Write Wezlana Pediatric IBD Substitution
By Ran Chen#Biosimilars#Interchangeability#Purple Book
Policy· August 30, 2026 · 17 min read
FDA Licensed XFG COVID Vaccines: Part B Differs from ACIP and ACA 2713
Specialty· August 30, 2026 · 23 min read
Libre Duo's Dual Glucose-Ketone De Novo Is Not a Medicare CGM Coverage Decision
Approvals· August 30, 2026 · 16 min read
Mounjaro's CV Claim Is Noninferiority vs Trulicity, Not Placebo Superiority
By Ran Chen#GLP-1#GIP/GLP-1#Diabetes and Obesity