Last mentioned: Mar 24, 2026
Regulatory Warning
FDA flags misleading claims made by Patrick Soon-Shiong regarding off-label uses of Anktiva.
FDA Approval
Anktiva is approved for BCG-unresponsive NMIBC in combination with BCG.
Initial Rejection
FDA issues a Complete Response Letter (CRL) for Anktiva due to manufacturing deficiencies.
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.
ImmunityBio (IBRX) shares rallied following the European Commission's marketing authorization of ANKTIVA for BCG-unresponsive non-muscle invasive bladder cancer. This milestone marks the first international expansion for the IL-15 superagonist, significantly broadening its global commercial reach.
This page surfaces every story mentioning ImmunityBio across our biotech coverage. We track each entity's appearance over time so readers can trace how the narrative evolves — which developments are isolated incidents, which build into longer arcs, and which reframe how operators in the space think about the entity. Story selection uses the same multi-source verification gate applied across the rest of our coverage.
Read our editorial methodology for how we identify, deduplicate, and score entity references. Our glossary defines the technical terms used across stories on this page, and our trends index contextualizes individual developments against the longer-running biotech beat. Cross-entity comparisons live on our compare view.
| What you see | What it tells you |
|---|---|
| Story count | Number of distinct stories where ImmunityBio was a primary or referenced actor. |
| Recency clustering | Whether mentions are concentrated in a recent window (a news cycle) or distributed (a sustained arc). |
| Sentiment distribution | Aggregate sentiment of the stories mentioning this entity, weighted by impact score. |
| Cross-niche links | When the same entity surfaces in our sibling networks, we link to those views to enrich context. |