The EU Just Made Pre-Submission Advice Permanent. Your CTA Strategy Is Now Out of Date.
EMA's ACT EU advice pilot becomes permanent in January 2027, giving EU sponsors consolidated multi-country feedback before CTA submission....
Clinical Data Teams Shift Focus to AI Validation and Human Oversight
Clinical data teams now prioritize AI validation and human oversight in regulatory workflows, following FDA guidance on predetermined change...
Patient-Owned Health Data Model Reduces Clinical Trial Recruitment Redundancy
Patient-owned health data model reduces clinical trial recruitment redundancy by enabling persistent consent and longitudinal data sharing across studies.
Sionna Advances SION-451/SION-2222 Combo Based on SION-719 Analysis
Sionna advances SION-451/SION-2222 combo into Phase 2a trial for cystic fibrosis, building on insights from prior SION-719 analysis.
Tenax Pauses LEVEL-2 Enrollment to Narrow TNX-103 Patient Selection
Tenax pauses LEVEL-2 enrollment to refine TNX-103 patient selection after the initial trial missed its primary walking distance endpoint.
SYCUME meets primary endpoint in Phase 3 trial for inactive thyroid eye disease
SYCUME met its Phase 3 primary endpoint for inactive thyroid eye disease, showing significant proptosis reduction versus placebo at...
FDA Approves Tecentriq for Stage III dMMR Colon Cancer
FDA approves Tecentriq for stage III dMMR colon cancer as adjuvant treatment. ATOMIC trial showed improved disease-free survival when...
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.