FDA grants seventh approval under the National Priority Voucher Pilot Program

FDA

8 May 2026 - The US FDA today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.

Bizengri is the first drug approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Canada , Registration