The U.S. Food and Drug Administration said it is investigating the death of a pediatric patient that may be related to Takeda’s enzyme replacement therapy Adzynma. The agency flagged the event and is reviewing clinical details to assess causality and any safety signals tied to the product. Takeda’s Adzynma is used for a rare genetic blood disorder; regulators indicated the probe is ongoing and that further information will follow as the review proceeds. The investigation could affect labeling, monitoring requirements, or ongoing trials depending on outcomes.