Renaissance Pharma Limited, an Essential Pharma company, secures FDA Fast Track Designation and IND clearance for Daretabart (hu1418K322A) in high-risk neuroblastoma

FDA grants Fast Track Designation for Daretabart (hu1418K322A), recognising the significant unmet medical need in high-risk neuroblastoma and enabling access to accelerated and rolling review FDA clearance of IND application enables initiation of the SHINE Phase II/III clinical trial in relapse and refractory patients with high-risk neuroblastoma First commercial-scale GMP batch of Daretabart (hu1418K322A) successfully […]