Pierre Fabre Pharmaceuticals Inc (PFP), the US pharmaceutical subsidiary of French pharmaceutical and dermo-cosmetics company Pierre Fabre Laboratories, announced on Monday the transfer of the Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics Inc (Nasdaq:ATRA).
Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel worldwide.
The FDA Prescription Drug User Fee Act (PDUFA) target action date for the tabelecleucel BLA is 10 January 2026. If approved, the innovative cell therapy will be indicated as monotherapy for treatment of adult and paediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
Tabelecleucel is manufactured by PFP in the United States for global clinical development and commercial access.
AVEO Oncology signs development and option agreement with HiberCell
Tabelecleucel's BLA transferred from Atara Biotherapeutics to Pierre Fabre Laboratories
UCB's KYGEVVI receives FDA approval for TK2d treatment
Camurus launches Oczyesa in Germany for patients with acromegaly
Servier's VORANIGO (vorasidenib) receives Prix Galien USA Award
Bavarian Nordic secures new EU contract for up to 8 million smallpox and mpox vaccine doses
GenSight Biologics secures FDA authorisation for expanded access to GS010/LUMEVOQ in the US
Ascletis Pharma Inc selects ASC36 as clinical development candidate
Zoetis announces EU approval for Portela to relieve osteoarthritis pain in cats
Samsung Bioepis to assume European commercialisation of BYOOVIZ (ranibizumab) from January 2026
Thermo Fisher Scientific to acquire Clario Holdings, expanding clinical data capabilities
Shanton Pharma completes SAP-001 End-of-Phase 2 meeting with US FDA
Eli Lilly's single-injection, once-monthly maintenance Omvoh regimen receives US FDA approval