Orviglance, positioned as the first and only gadolinium-free liver MRI contrast agent for this patient group, has received Orphan Drug Designation. Constructive feedback from the FDA has confirmed the NDA filing remains on track for mid-2025. Scientific recognition is growing, with 2025 data accepted at ESGAR, ISPOR, and RSNA, underlining clinical relevance and engagement from radiologists, nephrologists, and oncologists.

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