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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval