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At least four PDUFA dates on FDA’s November docket

Decisions expected for Arrowhead siRNA, Kura AML small molecule

October 31, 2025 9:08 PM UTC

FDA has at least four PDUFA dates on its November calendar, led by the Nov. 18 deadline for plozasiran to treat familial chylomicronemia syndrome.

Plozasiran is an siRNA targeting APOC3 and would become the first approved product for Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR). The company said in August it would be ready to launch immediately...