Posted by Michael Wonder on 26 Oct 2023
FDA accepts ImmunityBio’s BLA resubmission as complete and sets new PDUFA date
26 October 2023 - A new PDUFA date of 23 April 2024 has been communicated by the Agency.
ImmunityBio today announced that the US FDA has accepted for review ImmunityBio’s resubmission of its biologics license application for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease, and considered it as a complete response to the FDA’s 9 May 2023 complete response letter.
