ImmunityBio Addresses FDA Correspondence and Reaffirms Commitment to Advertising Compliance

Company initiated a comprehensive review of promotional materials and is implementing enhanced advertising compliance measures.

Apr. 6, 2026 at 1:54pm

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ImmunityBio, Inc., a commercial-stage immunotherapy company, has submitted a comprehensive response to the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) regarding issues raised on March 13, 2026 related to a television advertisement and a podcast. The company addressed the concerns related to the podcast and informed OPDP that the television advertisement was never aired.

Why it matters

This case highlights ImmunityBio's commitment to maintaining accurate and compliant promotional communications for its approved therapy ANKTIVA®. The company's proactive steps to address the OPDP's concerns and implement enhanced internal protocols demonstrate its dedication to regulatory compliance in the highly regulated pharmaceutical industry.

The details

ImmunityBio has taken proactive steps to address the OPDP's concerns, including the removal of the identified podcast from its corporate website and requesting its removal from third-party platforms. Additionally, the company confirmed that a television advertisement mentioned in the OPDP letter was never broadcast or disseminated to the public. The company is implementing a robust suite of corrective actions and compliance enhancements, including mandatory executive training, expanded Promotional Review Committee (PRC) protocols, and the engagement of external regulatory counsel to audit future high-visibility communications.

  • On March 13, 2026, the FDA Office of Prescription Drug Promotion (OPDP) raised issues related to a television advertisement and a podcast.
  • ImmunityBio submitted a comprehensive response to the OPDP on April 6, 2026.

The players

ImmunityBio, Inc.

A commercial-stage immunotherapy company focused on innovating, developing, and commercializing next-generation immunotherapies.

Richard Adcock

President and CEO of ImmunityBio.

Dr. Patrick Soon-Shiong

Founder and Executive Chairman of ImmunityBio.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Office of Prescription Drug Promotion (OPDP)

A division of the FDA that oversees the advertising and promotion of prescription drugs.

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What they’re saying

“ImmunityBio takes promotional compliance with the utmost seriousness. We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies. We believe our substantive remedial actions and enhanced internal protocols address the Agency's concerns.”

— Richard Adcock, President and CEO of ImmunityBio

What’s next

ImmunityBio will continue to work closely with the FDA to ensure all promotional communications for ANKTIVA® are accurate, balanced, and compliant with regulations.

The takeaway

This case highlights ImmunityBio's commitment to regulatory compliance and transparency in its promotional activities. The company's proactive response and implementation of enhanced internal protocols demonstrate its dedication to maintaining the highest standards of advertising and marketing practices in the pharmaceutical industry.