(RTTNews) - Atara Biotherapeutics (ATRA) has resubmitted a Biologics License Application to the FDA for tabelecleucel - EBVALLO or tab-cel - indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
Cokey Nguyen, CEO of Atara, said: "We look forward to continued engagement with the FDA throughout its review and with Pierre Fabre Laboratories as they actively prepare for the potential launch of this innovative therapy in the U.S."
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