Approvals· September 5, 2026 · 29 min read
Topic
Accelerated Approval
Surrogate endpoints, confirmatory trials, withdrawal risk, payer skepticism, and commercial exposure.
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
Specialty· August 14, 2026 · 24 min read
Multiple Myeloma Treatment Access Landscape: Generic Revlimid, Zenbexus, & Darzalex
Approvals· August 13, 2026 · 25 min read
Tudriqev (RP1): FDA Approval of Second Oncolytic Virus for Melanoma
By Ran Chen#FDA Approval#Accelerated Approval#Oncology
Pricing & Access· July 13, 2026 · 17 min read
Duchenne Muscular Dystrophy Access Landscape: Elevidys, Oligonucleotides, and Duvyzat
By Ran Chen#Rare Disease#Gene Therapy#HCPCS Coding
Approvals· July 3, 2026 · 17 min read
Yuviwel (navepegritide) FDA approval and once-weekly achondroplasia access
Approvals· June 11, 2026 · 10 min read
FDA Commissioner's National Priority Voucher program: what launch teams need to know
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 28, 2026 · 7 min read
Beqalzi coverage guide: sonrotoclax access in mantle cell lymphoma
Policy· May 22, 2026 · 10 min read