ImmunityBio resubmits cancer treatment application to FDA
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ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data
March 9, 2026 7:30 AM EDTFollowing multiple meetings with the FDA, ImmunityBio submitted additional information requested by the Agency to support its supplemental BLA (sBLA) for papillary diseaseThe FDA reviewed the additional data provided by ImmunityBio in February 2026, and based on the Agency's feedback, the Company resubmitted the sBLAThe FDA has acknowledged receipt of the resubmitted filingThe sBLA aims to address the unmet need for patients with papillary-only NMIBC, supported by what is believed to be the longest... More
