The U.S. Food and Drug Administration approves Replimune’s melanoma treatment on its third attempt, according to reporting from multiple outlets. Both sources say the FDA previously rejected the therapy twice. The earlier decisions are described as being tied to concerns about the quality and design of the clinical data submitted to support approval. The Wall Street Journal characterizes the prior refusals as stemming from concerns about clinical data quality, while Quartz focuses on concerns related to how the clinical trial was designed and how that design affected the evidence presented. With the third application, the FDA determines the submission is sufficient for approval, leading to authorization of the engineered viral therapy for melanoma. The outlets do not detail specific changes made between submissions, the scope of the approved indication beyond melanoma, or the trial outcomes. The reporting overall indicates that regulatory review centers on addressing the FDA’s earlier critiques of the clinical evidence, and that the company ultimately receives approval after meeting the agency’s requirements on resubmission.