The U.S. Food and Drug Administration (FDA) provides the Prescription Drug User Fee Act date which marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee meeting is convened to assess drugs or devices under consideration. Presented below is a compiled list of drugs, along with the anticipated decision date currently accurate as of October 30, 2025.

Upcoming FDA Decisions for November 2025

Plozasiran (NDA), November 18

  • Arrowhead Pharmaceuticals
  • For the treatment of familial chylomicronemia syndrome.

Sevabertinib (NDA), November 28

  • Bayer AG
  • For the treatment of patients with non-small cell lung cancer harboring HER2 activating mutations.

Sibeprenlimab (BLA), November 28

  • Otsuka Holdings
  • Treatment of Immunoglobulin A Nephropathy (IgAN) in adults.

TransCon CNP (NDA), November 30

  • Ascendis Pharma
  • For the treatment of children with achondroplasia.

Ziftomenib (NDA), November 30

  • Kura Oncology
  • Treatment for adult patients with relapsed or refractory acute myeloid leukemia with a nucleophosmin 1 mutation.

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