Ascelia Pharma: Bridging the Gap Between Phase III Success and FDA Approval
19 augusti, 14:47
19 augusti, 14:47
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.
19 augusti, 14:47
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.
Analys
Nibes kvartal
Aktierekommendationer
Aktier
Analys
Nibes kvartal
Aktierekommendationer
Aktier
1 DAG %
Senast
OMX Stockholm 30
1 DAG %
Senast
2 689,35