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AbbVie Submits Biologics License Application to FDA for Rare Blood Cancer Treatment
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AbbVie Submits Biologics License Application to FDA for Rare Blood Cancer Treatment
Sep 30, 2025 5:45 AM

08:24 AM EDT, 09/30/2025 (MT Newswires) -- AbbVie ( ABBV ) said Tuesday it submitted a new biologics license application to the US Food and Drug Administration seeking approval of its investigational therapy pivekimab sunirine to treat blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive blood cancer.

The drugmaker said the application is based on data from a global phase 1/2 trial evaluating the safety and efficacy of the therapy.

Shares were down 1.5% in recent premarket activity.

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