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

By SquaredTown on March 9, 2026

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

Following multiple meetings with the FDA, ImmunityBio submitted additional information requested by the Agency to support its supplemental BLA (sBLA) for papillary disease The FDA reviewed the additional data provided by ImmunityBio in February 2026, and based on the Agency's feedback,...

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