Theriva Biologics announced that the European Commission has adopted the European Medicines Agency, EMA, recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma. The United States Food and Drug Administration, FDA, has previously granted orphan drug designation and rare pediatric disease designation to VCN-01 for the treatment of retinoblastoma.
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