Policy· August 21, 2026 · 19 min read
Reject China Trial Data Without Audits: What the Moolenaar Letter Would Do
By Ran Chen#Clinical Trials#Regulatory#China
Topic
Clinical Trials
Clinical trial design, regulatory evidence requirements, innovative trial methodologies, and evidence generation strategies.
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 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
Policy· August 2, 2026 · 29 min read
EU Clinical Trials by the Numbers 2026: 12,123 CTIS Records Analyzed
By Ran Chen#Clinical Trials#EMA#Clinical Evidence
Pipeline· August 2, 2026 · 26 min read
In Vivo CAR-T by the Numbers 2026: $17.9B in Deals vs 23 Phase 1 Trials
By Ran Chen#CAR-T#Clinical Trials#Oncology
Manufacturing· August 1, 2026 · 20 min read
FDA Warning Letters by the Numbers (2026): CDER Drug Enforcement Surge
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