Phase III trial of cadonilimab begins in perioperative colon cancer
Phase III trial of cadonilimab begins in perioperative colon cancer, testing dual PD-1/CTLA-4 blockade in MSI-H/dMMR patients seeking pathological...
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...
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.