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
Topic
PDUFA Date
FDA action-date calendars, review milestones, launch readiness, and what teams should monitor before decisions.
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 23, 2026 · 18 min read
Besremi's August 30 ET PDUFA: Second-Line vs Anagrelide, Not Hydroxyurea
By Ran Chen#PDUFA Date#FDA Approval#Orange Book
Specialty· August 14, 2026 · 20 min read
Spinal Muscular Atrophy Treatment Access Landscape: Spinraza, Itvisma, & Evrysdi
By Ran Chen#Rare Disease#Gene Therapy#Antisense
Approvals· August 12, 2026 · 34 min read
Gilead's BIC/LEN Single-Tablet HIV Regimen: PDUFA, Phase 3, and Access
By Ran Chen#FDA Approval#HIV#Gilead Sciences
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
Pipeline· August 11, 2026 · 14 min read
Ivonescimab: the PD-1/VEGF Bispecific Ahead of Nov 2026 FDA Action
By Ran Chen#FDA Approval#Oncology#Bispecific Antibody
Approvals· August 11, 2026 · 20 min read
Orzeyful (Oveporexton): the First Orexin-2 Agonist, FDA-Approved for Narcolepsy Type 1
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