Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year. This marks a significant step forward in the development of Vididencel, a potential treatment derived from leukemia cells, aimed at leveraging the body's immune system to fight cancer. The regulatory clearance paves the way for the initiation of a registration trial, which is crucial for the vaccine's path to market approval.
Sweden's Mendus Clears Regulatory Path For Vididencel Registration Trial

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Sweden's Mendus Clears Regulatory Path For Vididencel Registration Trial
insights.citeline.comJan 3, 2025