The European Medicines Agency is expected to decide this week whether to fast track its assessment of the planned EU marketing authorization applications for two investigational products – tabelecleucel (tab-cel) and mosunetuzumab.
Tab‐cel, from Atara Biotherapeutics, is an off-the-shelf, allogeneic T-cell immunotherapy for treating Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)
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