🇺🇸 Niktimvo in United States

FDA authorised Niktimvo on 14 August 2024

Marketing authorisations

FDA — authorised 14 August 2024

Application: BLA761411
Marketing authorisation holder: INCYTE CORP
Local brand name: NIKTIMVO
Indication: INJECTABLE — INTRAVENOUS
Status: approved

The FDA approved Niktimvo, a new molecular entity, for marketing in the United States. The approval was granted to INCYTE CORP on 14 August 2024, following a standard expedited pathway. The application number for this approval is BLA761411.

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FDA

Marketing authorisation holder: INCYTE CORP
Status: approved

Niktimvo in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Niktimvo approved in United States?

Yes. FDA authorised it on 14 August 2024; FDA has authorised it.

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

INCYTE CORP holds the US marketing authorisation.