FDA plans to drop the de facto two-pivotal-trial expectation, requiring one adequate and well-controlled study plus confirmatory evidence to support approval. Scientific justification centers on ...
Phase I Study of 131I-Metaiodobenzylguanidine With Dinutuximab ± Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A New Approaches to Neuroblastoma Therapy Trial While the ...
Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non–Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B) Patients with unresected ...
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