🇺🇸 ZYNYZ in United States

FDA authorised ZYNYZ on 22 March 2023

Marketing authorisation

FDA — authorised 22 March 2023

  • Application: BLA761334
  • Marketing authorisation holder: INCYTE CORP
  • Local brand name: ZYNYZ
  • Indication: INJECTABLE — INTRAVENOUS
  • Status: approved

The FDA approved ZYNYZ, a drug developed by INCYTE CORP, on 2025-05-15. The approval was granted under the standard expedited pathway. The approved indication for ZYNYZ is for its efficacy, but the specific indication is not reported in the available data.

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ZYNYZ in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is ZYNYZ approved in United States?

Yes. FDA authorised it on 22 March 2023.

Who is the marketing authorisation holder for ZYNYZ in United States?

INCYTE CORP holds the US marketing authorisation.