EMA's ACT EU advice pilot becomes permanent in January 2027, giving EU sponsors consolidated multi-country feedback before CTA submission. Here's what ...
Clinical data teams now prioritize AI validation and human oversight in regulatory workflows, following FDA guidance on ...
Patient-owned health data model reduces clinical trial recruitment redundancy by enabling persistent consent and longitudinal ...
Tenax pauses LEVEL-2 enrollment to refine TNX-103 patient selection after the initial trial missed its primary walking ...
FDA approves Tecentriq for stage III dMMR colon cancer as adjuvant treatment. ATOMIC trial showed improved disease-free survival when added to chemotherapy.
Sionna advances SION-451/SION-2222 combo into Phase 2a trial for cystic fibrosis, building on insights from prior SION-719 ...
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