ImmunityBio Addresses FDA Correspondence and Reaffirms Commitment to Advertising Compliance
ImmunityBio • • business
Key Points:
- ImmunityBio has responded to FDA concerns by removing a podcast from its website and third-party platforms, confirming that the cited television advertisement was never aired, and initiating a comprehensive review of its promotional materials.
- The company is implementing enhanced compliance measures including expanded promotional review protocols, mandatory executive training, and external regulatory oversight to ensure adherence to FDA regulations.
- Clarifications were provided regarding statements made by the company’s founder during a podcast, emphasizing that remarks were aspirational and related to investigational research, not approved product claims.
- ANKTIVA® (nogapendekin alfa inbakicept-pmln), ImmunityBio’s IL-15 receptor agonist, is approved for use with BCG in treating certain bladder cancers, with detailed safety information and usage guidelines provided.
- ImmunityBio reaffirmed its commitment to accurate and balanced promotional communications and outlined its strategy to develop next-generation immunotherapies targeting cancer and infectious diseases.
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