ImmunityBio received an FDA warning letter for promotional materials related to Anktiva, including a TV ad and podcast episode.
This marks the first untitled letters from the FDA in 2026.
The FDA cited BeOne and ImmunityBio for issues in these Anktiva promotions.
Separate FDA actions include a refusal-to-file letter in May 2025 for Anktiva's sBLA in BCG-unresponsive NMIBC papillary disease without CIS, which ImmunityBio disputes.