ImmunityBio, Inc. announced that the U.S. Food and Drug Administration 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 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 May 9, 2023 complete response letter.
October 26, 2023
· 7 min read