$ATRA
Пьер Фабре: "Ещё побарахтаемся!"
Pierre Fabre Pharmaceuticals, in partnership with Atara, submitted a briefing book to the FDA addressing the points from the Complete Response Letter dated January 9, 2026, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tabelecleucel (tab-cel) Biologics License Application. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission.