🇺🇸 Imdelltra (Amg757) in United States

FDA authorised Imdelltra (Amg757) on 16 May 2024

Marketing authorisations

FDA — authorised 16 May 2024

Application: BLA761344
Marketing authorisation holder: AMGEN INC
Indication: Type 1 - New Molecular Entity
Status: approved

The FDA approved Imdelltra (Amg757), a new molecular entity, on 16 May 2024. The marketing authorisation holder is AMGEN INC. The application was submitted under the standard expedited pathway. The indication approved for Imdelltra (Amg757) is Type 1, which refers to a new molecular entity.

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FDA

Marketing authorisation holder: AMGEN INC
Status: approved

Imdelltra (Amg757) 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 Imdelltra (Amg757) approved in United States?

Yes. FDA authorised it on 16 May 2024; FDA has authorised it.

Who is the marketing authorisation holder for Imdelltra (Amg757) in United States?

AMGEN INC holds the US marketing authorisation.