Specialty· August 14, 2026 · 20 min read
Spinal Muscular Atrophy Treatment Access Landscape: Spinraza, Itvisma, & Evrysdi
By Ran Chen#Rare Disease#Gene Therapy#Antisense
Topic
PDUFA Date
FDA action-date calendars, review milestones, launch readiness, and what teams should monitor before decisions.
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
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
Deals· August 1, 2026 · 20 min read
Gilead's $5B Tubulis Buyout: Deal Anatomy & NaPi2b ADC Platform
By Ran Chen#M&A#ADC#FDA Approval
Pipeline· July 31, 2026 · 20 min read
mRNA Vaccines Pipeline by the Numbers (2026): 459 Clinical Trials
By Ran Chen#Clinical Trials#RNA Therapy#FDA Approval
Pipeline· July 1, 2026 · 19 min read
Centanafadine PDUFA July 24, 2026: Pipeline and Access for Otsuka's NDSRI
By Ran Chen#PDUFA Date#Priority Review#CNS and Migraine