The FDA issued a warning letter to ImmunityBio over what the agency described as false and misleading marketing claims for Anktiva, including messaging in a podcast and television advertisements. The FDA said the content created a misleading impression that Anktiva could cure or prevent all cancers, and it faulted the communications for omitting risk and key usage requirements. The warning emphasizes that Anktiva’s approved positioning depends on combination use with a vaccine, and the FDA said the marketing downplayed risks and overstated outcomes beyond the supporting clinical evidence. The action adds to regulatory scrutiny on how oncology therapies are portrayed outside strict labeling language. For biotech and med-tech stakeholders, the enforcement move is a reminder to align promotional narratives with indication scope, combination requirements, and the granularity of trial-supported claims—especially for complex cell and immunotherapy regimens.