Biologics License Application seeking approval of naxitamab for relapsed/refractory high-risk neuroblastoma submitted to the US FDA

Naxitamab is an investigational monoclonal antibody that targets GD2, a disialoganglioside that is expressed on almost all neuroblastoma cells, but with a highly restricted expression on normal tissue. It has been designated as an orphan drug in the EU and US for this condition.


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