Approvals· September 5, 2026 · 29 min read
Topic
NDA Approval
New Drug Application approval strategy, review packages, labeling, exclusivity, and commercial launch implications.
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 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
Approvals· August 22, 2026 · 19 min read
Zilganersen's September 22 PDUFA: Alexander Disease ASO & Intrathecal Access
By Ran Chen#FDA Approval#NDA Approval#Priority Review
Generics· June 14, 2026 · 10 min read
Single-source inhaled drugs in the Orange Book: 506 products, 65% no generic
By Ran Chen#Orange Book#ANDA Approval#Generic Entry
Generics· June 14, 2026 · 11 min read
Single-source ophthalmic drops in the Orange Book: 67 molecules, 11% AB-substitutable
By Ran Chen#Orange Book#ANDA Approval#Generic Entry
Approvals· June 8, 2026 · 9 min read
FDA drug-device combination product pathway: PMOA and launch strategy
Pipeline· June 5, 2026 · 12 min read
Gedatolisib PDUFA preview: pan-PI3K/mTOR inhibitor targets HR+/HER2– breast cancer gap
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Approvals· May 25, 2026 · 8 min read