14/04/2026 FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma ( Ref ) Renaissance Pharma's Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody, has received Fast Track status from the U.S. FDA for treating high-risk neuroblastoma (HRNB), a rare pediatric cancer Clinical trial progress: The FDA has cleared the IND application, enabling the start of the SHINE Phase II/III clinical trial in r