Last mentioned: Mar 24, 2026
FDA Warning Issued
The FDA flags the podcast statements as misleading and issues an Untitled Letter to ImmunityBio.
Podcast Appearance
Patrick Soon-Shiong discusses the drug's potential on a high-profile industry podcast.
Initial FDA Approval
Anktiva (N-803) receives FDA approval for BCG-unresponsive NMIBC.
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.
This page surfaces every story mentioning FDA across our healthcare 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 healthcare beat. Cross-entity comparisons live on our compare view.
| What you see | What it tells you |
|---|---|
| Story count | Number of distinct stories where FDA 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. |