New agency documents show the FDA’s Center for Biologics Evaluation and Research granted an accelerated approval for Replimune’s melanoma treatment Tudriqev after an FDA official overruled an internal review team rejection. The decision marks a high-profile example of how oversight can shift late in the approval process. The approval was for an accelerated pathway, indicating the agency relied on earlier clinical evidence that requires confirmatory follow-up. The records cite Asha Das, director of the biologics center’s office of clinical evaluation, as the official who overrode the earlier assessment. The case highlights ongoing scrutiny of accelerated approvals and the internal governance mechanisms that determine whether a therapy clears regulatory hurdles—particularly where the evidentiary bar is inherently more conditional.