FDA grants orphan drug status to Soligenix’s dusquetide
This designation comes after the FDA Office of Orphan Products Development reviewed recent Phase IIa clinical trial results, which showed both biological efficacy and safety in patients with
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Replimune Group’s biologics licence application (BLA) concerning the RP1 therapy in combination with nivolumab for advanced melanoma.