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Federal regulators have intensified scrutiny of pharmaceutical marketing claims, issuing warnings to two major drugmakers over misleading statements about their products. The U.S. Food and Drug Administration (FDA) has taken action against Amgen’s autoimmune drug Tavneos and ImmunityBio’s cancer treatment Anktiva, citing concerns over efficacy data and promotional claims that extend beyond approved uses.

FDA Moves to Withdraw Amgen’s Tavneos Over Alleged Data Manipulation

The FDA announced on Tuesday that We see proposing to withdraw approval for Amgen’s Tavneos (avacopan), a drug approved in 2021 for the treatment of a rare autoimmune condition called anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The agency cited “untrue statements of material fact” in the drug’s approval application, including allegations that study personnel manipulated data to exaggerate the drug’s effectiveness.

In a statement, the FDA’s Center for Drug Evaluation and Research (CDER) said the agency had discovered new evidence indicating that Tavneos “lacks substantial evidence of effectiveness” for its approved use. The drug was initially approved under the FDA’s accelerated approval pathway, which allows earlier access to treatments for serious conditions based on preliminary data, with the requirement that confirmatory trials verify clinical benefit. The FDA now contends that the confirmatory data do not support the drug’s continued approval.

Amgen has resisted the FDA’s call for voluntary withdrawal, asserting that Tavneos remains safe and effective for patients. The company stated on its website that it “continues to believe in the benefit-risk profile of Tavneos” and is “evaluating all available options” to keep the drug on the market. The FDA’s proposal to withdraw approval will now proceed to a formal hearing process, where Amgen will have the opportunity to present its case.

ImmunityBio’s Anktiva Faces FDA Warning Over Cancer Claims

Separately, the FDA issued a warning letter to ImmunityBio Inc. Over misleading promotional claims about its bladder cancer drug Anktiva (nogapendekin alfa inbakicept-pmln). The drug, approved in 2024 for a hard-to-treat form of bladder cancer, has been the subject of aggressive marketing by the company’s executive chairman and chief medical officer, Dr. Patrick Soon-Shiong, who has publicly claimed that Anktiva could treat, cure, or even prevent other types of cancer.

The FDA’s letter, posted online on Tuesday, stated that a television advertisement and a January 2026 podcast interview featuring Soon-Shiong contained “false or misleading” statements about Anktiva’s capabilities. The agency noted that the claims “create a misleading impression” about the drug’s approved uses and suggest it is intended for conditions for which it lacks regulatory clearance. Specifically, the FDA took issue with Soon-Shiong’s statements that Anktiva “can treat all cancers” and could “prevent cancer if you were exposed to radiation.”

ImmunityBio’s shares fell more than 21% following the FDA’s announcement, closing at $7.42 on Tuesday. The company has been working to expand Anktiva’s approved uses to include lung and pancreatic cancers, but the FDA’s warning underscores the regulatory risks of promoting unapproved indications. In response to the letter, ImmunityBio has not yet issued a public statement addressing the specific claims made by Soon-Shiong.

Broader Implications for Drug Marketing and Regulatory Oversight

These actions reflect the FDA’s growing emphasis on holding drugmakers accountable for promotional claims, particularly in an era of rapid biotechnological advancement and high-stakes drug development. The agency’s warning letters serve as a reminder that even approved drugs remain subject to ongoing scrutiny, especially when companies seek to expand their use into new therapeutic areas.

For Tavneos, the FDA’s proposal to withdraw approval highlights the risks associated with the accelerated approval pathway, which has come under criticism for allowing drugs to reach the market based on surrogate endpoints that may not always translate into meaningful clinical benefits. The pathway has been a flashpoint in debates over drug pricing and patient access, with some arguing that it enables faster innovation while others contend it exposes patients to treatments with unproven efficacy.

In the case of Anktiva, the FDA’s warning underscores the challenges of marketing drugs in a competitive oncology landscape, where companies often seek to position their products as breakthroughs. The agency’s letter specifically cited the potential for Soon-Shiong’s claims to mislead patients and healthcare providers about the drug’s safety and effectiveness for unapproved uses. The FDA warned that such statements could lead to “unreasonable risks” if patients or providers rely on them to make treatment decisions.

Financial and Industry Reactions

The FDA’s actions have already had financial repercussions for both companies. Amgen’s stock price remained relatively stable following the announcement, reflecting investor confidence in the company’s broader pipeline. However, the potential withdrawal of Tavneos could have significant implications for patients who rely on the drug, as well as for Amgen’s revenue streams. Tavneos generated approximately $300 million in sales in 2025, according to the company’s annual report.

For ImmunityBio, the 21% drop in share price following the FDA’s warning letter signals investor concern about the company’s ability to expand Anktiva’s market. The drug was initially hailed as a potential game-changer for bladder cancer patients, particularly those who do not respond to existing therapies. However, the FDA’s warning may slow the company’s efforts to secure additional approvals, as regulators may now scrutinize its data more closely.

The broader biotech and pharmaceutical industry is closely watching these developments, as they could set precedents for how the FDA handles promotional claims and post-approval data integrity. Companies may face increased pressure to ensure that their marketing materials align strictly with approved indications and that their clinical trial data are robust and transparent.

What Comes Next

For Amgen, the next steps will involve navigating the FDA’s formal hearing process to contest the proposed withdrawal of Tavneos. The company has not yet indicated whether it will submit additional data to support the drug’s continued approval, but industry analysts suggest that Amgen may seek to negotiate a compromise with the FDA, such as a label update or restricted use.

ImmunityBio, meanwhile, will need to address the FDA’s concerns about its promotional claims. The company may be required to issue corrective statements or pull misleading advertisements, and it could face further regulatory action if it continues to promote Anktiva for unapproved uses. The FDA’s warning letter does not constitute a formal enforcement action, but it signals the agency’s willingness to intervene if the company does not comply.

For patients and healthcare providers, these developments serve as a reminder of the importance of relying on approved indications and verified data when making treatment decisions. The FDA’s actions underscore the need for transparency in drug marketing and the potential risks of overstating a drug’s capabilities before robust clinical evidence is available.

As the biotech and pharmaceutical industries continue to innovate, the balance between accelerating patient access to new treatments and ensuring their safety and efficacy remains a critical challenge. The outcomes of these cases could shape the regulatory landscape for years to come, influencing how drugs are approved, marketed, and monitored post-approval.