🇺🇸 WEZLANA in United States

FDA authorised WEZLANA on 31 October 2023

Marketing authorisations

FDA — authorised 31 October 2023

  • Application: BLA761331
  • Marketing authorisation holder: AMGEN INC
  • Local brand name: WEZLANA
  • Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
  • Status: approved

The FDA granted marketing authorisation to WEZLANA, a drug developed by AMGEN INC, on 25 September 2025. The marketing authorisation was granted under the standard expedited pathway. The approved indication for WEZLANA is labelled, but the specific indication is not reported in the available data.

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FDA — authorised 31 October 2023

  • Application: BLA761285
  • Marketing authorisation holder: AMGEN INC
  • Local brand name: WEZLANA
  • Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
  • Status: approved

The FDA granted marketing authorisation to WEZLANA, a drug developed by AMGEN INC, on 25 September 2025. The marketing authorisation was granted under the standard expedited pathway. The approved indication for WEZLANA is listed as 'Labeling', but the specific indication is not specified in the available information.

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WEZLANA in other countries

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

Other Other approved in United States

Frequently asked questions

Is WEZLANA approved in United States?

Yes. FDA authorised it on 31 October 2023; FDA authorised it on 31 October 2023.

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

AMGEN INC holds the US marketing authorisation.