Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease

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Class action lawsuits allege securities violations by Atara Biotherapeutics and Inovio Pharmaceuticals related to FDA submissions. Atara faces claims over manufacturing issues with its tabelecleucel BLA, while Inovio is accused of misleading statements about INO-3107 regulatory timelines and manufacturing deficiencies.

Atara Biotherapeutics Schedules FDA Meeting on Tabelecleucel Application

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Atara Biotherapeutics announced a Type A meeting with the FDA to discuss the Complete Response Letter for tabelecleucel's Biologics License Application, held by partner Pierre Fabre Pharmaceuticals.

Atara Seeks FDA Meeting After Complete Response Letter for Ebvallo

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The FDA issued a Complete Response Letter for Atara Biotherapeutics' Ebvallo application, reversing its prior acceptance of the ALLELE trial design. Partner Pierre Fabre Pharmaceuticals has requested a Type A meeting to address the agency's concerns.