🇺🇸 Ojemda in United States

FDA authorised Ojemda on 23 April 2024

Marketing authorisations

FDA — authorised 23 April 2024

Application: NDA218033
Marketing authorisation holder: DAY ONE BIOPHARMS
Local brand name: OJEMDA
Indication: FOR SUSPENSION — ORAL
Status: approved

The FDA approved Ojemda, a drug developed by DAY ONE BIOPHARMS, on 27 August 2025. The approval was granted under the standard expedited pathway. The marketing authorisation holder is DAY ONE BIOPHARMS, and the application number is NDA218033.

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FDA — authorised 23 April 2024

Application: NDA217700
Marketing authorisation holder: DAY ONE BIOPHARMS
Local brand name: OJEMDA
Indication: TABLET — ORAL
Status: approved

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FDA

Marketing authorisation holder: DAY ONE BIOPHARMS
Status: approved

Ojemda 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 Ojemda approved in United States?

Yes. FDA authorised it on 23 April 2024; FDA authorised it on 23 April 2024; FDA has authorised it.

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

DAY ONE BIOPHARMS holds the US marketing authorisation.