🇺🇸 Modeyso in United States

FDA authorised Modeyso on 6 August 2025

Marketing authorisations

FDA — authorised 6 August 2025

Application: NDA219876
Marketing authorisation holder: CHIMERIX
Local brand name: MODEYSO
Indication: CAPSULE — ORAL
Status: approved

The FDA approved Modeyso, a new molecular entity, on August 6, 2025. The approval was granted to CHIMERIX under the standard expedited pathway. The indication for Modeyso is not specified in the provided information, but it is classified as a Type 1 New Molecular Entity.

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FDA

Marketing authorisation holder: CHIMERIX
Status: approved

Modeyso 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 Modeyso approved in United States?

Yes. FDA authorised it on 6 August 2025; FDA has authorised it.

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

CHIMERIX holds the US marketing authorisation.