
The FDA has accepted Pierre Fabre Pharmaceuticals’ resubmitted BLA for tabelecleucel, an allogeneic T-cell immunotherapy for EBV+ post-transplant lymphoproliferative disease. The FDA’s target action date is March 31, 2027.
The Sartorius-developed software, the Extractables Simulator, allows flexible combination of multiple component extractables data and prediction to facilitate the use of single-use systems in critical processing operations.






