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Takeda Gets FDA Approval for Expanded Label for Bleeding Disorder Therapy
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Takeda Gets FDA Approval for Expanded Label for Bleeding Disorder Therapy
Sep 8, 2025 2:19 AM

04:59 AM EDT, 09/08/2025 (MT Newswires) -- Takeda Pharmaceutical ( TAK ) said late Friday that the US Food and Drug Administration approved an expanded indication for its Vonvendi von Willebrand disease therapy to include routine prophylaxis for adult patients and on-demand and perioperative management of bleeding in pediatric patients.

The drug was previously approved for on-demand perioperative use and routine prophylactic use in adult patients with the bleeding disorder.

The company has pending regulatory applications for the drug in Japan and the European Union.

Takeda shares were up 2.5% in recent premarket activity Monday.

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