Last mentioned: Mar 25, 2026
Expected Regional Launch
Anticipated availability of ANKTIVA in Macau oncology centers.
Compliance Review
Industry analysts begin evaluating the impact on ImmunityBio's internal promotional controls.
Macau SAR Approval
Macau Health Bureau grants regulatory clearance for ANKTIVA.
FDA Warning Issued
Federal health officials issue a formal warning over misleading statements made by Patrick Soon-Shiong.
Media Reports
Major outlets including Seattle Times and MedPage Today report on the regulatory crackdown.
FDA Warning Issued
The FDA flags the podcast statements as misleading and issues an Untitled Letter to ImmunityBio.
Regulatory Warning
FDA flags misleading claims made by Patrick Soon-Shiong regarding off-label uses of Anktiva.
Podcast Appearance
Patrick Soon-Shiong discusses the drug's potential on a high-profile industry podcast.
U.S. Commercial Launch
ImmunityBio begins commercial distribution of ANKTIVA in the U.S.
Initial FDA Approval
Anktiva (N-803) receives FDA approval for BCG-unresponsive NMIBC.
FDA Approval
Anktiva is approved for BCG-unresponsive NMIBC in combination with BCG.
U.S. FDA Approval
ANKTIVA receives first-ever approval for NMIBC in the United States.
Initial Rejection
FDA issues a Complete Response Letter (CRL) for Anktiva due to manufacturing deficiencies.
ImmunityBio Inc. has received regulatory approval for its flagship immunotherapy, ANKTIVA, in the Macau Special Administrative Region of China. This milestone marks the first international expansion for the IL-15 superagonist following its 2024 U.S. FDA approval, positioning the company to tap into the significant oncology market in the Greater Bay Area.
The FDA has issued a formal warning to Dr. Patrick Soon-Shiong, the billionaire founder of ImmunityBio, regarding misleading statements made about the company’s bladder cancer therapy, Anktiva. The regulator flagged claims made during a podcast that suggested the drug could treat a broader range of cancers than its current approval allows.
The FDA has issued a formal warning to ImmunityBio and its founder, Patrick Soon-Shiong, regarding misleading public statements about the company's bladder cancer drug. The regulator cited claims made during a podcast that suggested broader efficacy than currently approved, raising concerns about off-label promotion.
The FDA has issued a formal warning to billionaire Patrick Soon-Shiong regarding misleading promotional statements about ImmunityBio’s bladder cancer treatment. The regulatory action highlights a growing crackdown on off-label marketing conducted through non-traditional media channels like podcasts.