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Kanjinti (trastuzumab-anns) PDUFA Date (Amgen Inc)

FDA PDUFA decision date for Kanjinti (trastuzumab-anns) is December 19, 2024. Developed by Amgen Inc. Indication: HER2/neu Receptor Antagonist [EPC]. Current status: Approved.

Indication

HER2/neu Receptor Antagonist [EPC]

Regulatory details

  • Company: Amgen Inc
  • Application type: sBLA
  • Review type: Standard
  • PDUFA date: 2024-12-19
  • Outcome: Approved