Policy· September 7, 2026 · 34 min read
EClinCloud AI-Assisted Study Build: What Sponsors Must Accept Before EDC Go-Live
By Ran Chen#FDA#Regulatory#Clinical Trials
Topic
Clinical Trials
Clinical trial design, regulatory evidence requirements, innovative trial methodologies, and evidence generation strategies.
Evidence· August 29, 2026 · 23 min read
Treatment-Regimen Estimands in FDA Labels: Answering the Real Coverage Question
By Ran Chen#Clinical Evidence#Clinical Trials#FDA
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
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