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Atara says FDA accepts resubmitted Tab-cel BLA, sets March 31, 2027 PDUFA date

Atara says FDA accepts resubmitted Tab-cel BLA, sets March 31, 2027 PDUFA date

BitgetBitget2026/10/14 12:05
  • FDA accepted the resubmitted BLA for tabelecleucel (Tab-cel) to treat EBV+ PTLD in patients aged 2 and older.
  • Class 2 resubmission sets a PDUFA target action date of March 31, 2027.
  • Partner Pierre Fabre Pharmaceuticals filed the resubmission; Atara could receive a USD 31 million milestone if Tab-cel is cleared.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Atara Biotherapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202610140805BIZWIRE_USPR_____20261014_BW012366) on October 14, 2026, and is solely responsible for the information contained therein.

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