On Friday, October 11, 2025, the U.S. Food and Drug Administration approved labeling changes for Johnson & Johnson and Legend Biotech’s blood cancer therapy, adding a boxed warning for a potentially fatal gastrointestinal condition. This regulatory action directly affects the safety profile of the drug and requires immediate updates to prescribing information.
The boxed warning highlights a serious risk that could lead to fatal gastrointestinal complications, prompting clinicians to exercise heightened caution when prescribing the therapy. The addition may influence prescribing patterns, potentially reducing utilization and impacting the company’s revenue from the product.
The FDA’s decision underscores the importance of post‑marketing safety surveillance and may increase the company’s liability exposure. While the therapy remains a key component of J&J’s oncology portfolio, the warning could affect market perception and future sales, warranting close monitoring by investors and stakeholders.
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