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
Section
Approvals
FDA decisions, label language, review pathways, and what approvals imply for access and launch sequencing.
30 articles · Last updated
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
Approvals· August 11, 2026 · 20 min read
Orzeyful (Oveporexton): the First Orexin-2 Agonist, FDA-Approved for Narcolepsy Type 1
Approvals· August 10, 2026 · 14 min read
177Lu-Edotreotide (ITM-11) for GEP-NET: COMPETE Phase 3 Data and Lutathera Access
By Ran Chen#Radiolabeled Therapy#Oncology#FDA Approval
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
Approvals· August 5, 2026 · 16 min read
mFlusiva mRNA flu vaccine meets frozen ACIP: 2026-27 FDA decision and access
By Ran Chen#Infectious Disease#FDA Approval#PDUFA Date
Approvals· July 28, 2026 · 23 min read
Lytenava & Wet AMD: First FDA-Approved Ophthalmic Bevacizumab and Buy-and-Bill
By Ran Chen#FDA Approval#Wet AMD#Anti-VEGF
Approvals· July 27, 2026 · 18 min read
Sickle Cell Disease Treatment Access Landscape: Casgevy, Lyfgenia & Oxbryta
Approvals· July 16, 2026 · 22 min read