When the Factory Holds Up the Approval, Your Sites Are Already Paying for It
FDA extended Novo Nordisk's denecimig review over manufacturing remediation. Here's what sponsor clinops teams must do before the new...
The Eye as a Biomarker: Why Retinal AI Could Reshape How Trials Screen and Stratify Pregnant Patients
A Nature Biotechnology retinal AI model detects preeclampsia and gestational hypertension risk non-invasively, and its trial implications go far...
Ribo Files EU Trial Application for INHBE-Targeting Obesity Drug RBD3133
Ribo files EU Trial Application for RBD3133, an siRNA targeting INHBE for obesity treatment backed by human genetic evidence.
Jupiter Neurosciences Doses First Parkinson’s Patient in JOTROL Phase 2a Trial
Jupiter Neurosciences doses first Parkinson's patient in JOTROL Phase 2a trial, testing whether enhanced resveratrol achieves therapeutic brain concentrations.
Remibrutinib reduces relapse rates versus teriflunomide in Phase 3 MS trials
Remibrutinib reduces relapse rates versus teriflunomide in Phase 3 MS trials REMODEL-1 and REMODEL-2, with results presented at MSToronto2026.
FDA approves Rhapsido (remibrutinib) for symptomatic dermographism
FDA approves Rhapsido (remibrutinib) for symptomatic dermographism, the first prescription treatment for adults with the condition inadequately controlled by...
Where Clinical Trials Have Never Been: Rovia’s Case for Building Research Infrastructure in Forgotten Communities
Rovia grew a site network in places where sponsors needed patient access. Now sponsors are coming to him.
FDA’s Advisory Committee Rebuild Will Reshape Protocol Feedback Before Sponsors Realize It
FDA's September 2026 adcomm recruitment push signals shifts in protocol feedback loops that sponsor clinops and sites can't afford...
The Pragmatic Trial Has Been Hijacked. Here Is What It Was Actually Supposed to Do.
JAMA's 2026 editorial exposes how "pragmatic trial" has been stretched beyond recognition, threatening regulatory credibility and real-world evidence quality.
AI Deployment in Clinical Studies Requires Validation Framework and Governance Structure
AI deployment in clinical studies requires validation framework and governance structure to address compliance gaps and enable safe implementation.