Pierre Fabre Pharmaceuticals Resubmits Tabelecleucel Biologics License Application for Treatment of Epstein-Barr Virus Positive-Post-Transplant Lymphoproliferative Disease to the FDA

BLA FilingtabelecleucelPositive

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Summary

Pierre Fabre Pharmaceuticals resubmitted a Biologics License Application to the FDA for tabelecleucel, a treatment for relapsed/refractory EBV+ PTLD in transplant patients. If approved, tabelecleucel would be the first FDA-authorized therapy for this indication.

Outcome Details

Resubmission of Biologics License Application to the FDA

Importance:7/10

Sentiment:

0.60

FDABLA resubmissioncell therapyorphan indicationpost-transplant

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Published by PR Newswire Pharma on September 30, 2026 12:00 PM

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