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General MedicationsINTRAVENOUSStandard

ZYNYZ

RETIFANLIMAB-DLWR

Standard Dose
500MG/20ML(25MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ZYNYZ is listed in Drugs@FDA under application 761334 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RETIFANLIMAB-DLWR Form and strength INJECTABLE;INTRAVENOUS - 500MG/20ML(25MG/ML) Sponsor INCYTE CORP Submission history Latest submission status date: 2026-03-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZYNYZ is listed in Drugs@FDA under application 761334 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient RETIFANLIMAB-DLWR Form and strength INJECTABLE;INTRAVENOUS - 500MG/20ML(25MG/ML) Sponsor INCYTE CORP Submission history Latest submission status date: 2026-03-30 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.