Biotech News
ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027
Supplemental BLA seeks to expand the ANKTIVA label to include patients with BCG-unresponsive NMIBC with papillary disease FDA noted in its filing communication that the supplemental BLA accepted for review was based on the additional scientific data ImmunityBio provided at the Agency’s request,