🇺🇸 Vyloy in United States

FDA authorised Vyloy on 18 October 2024

Marketing authorisations

FDA — authorised 18 October 2024

Application: BLA761365
Marketing authorisation holder: ASTELLAS
Local brand name: VYLOY
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved Vyloy, a drug developed by Astellas, for its approved indication on 6 June 2025. The approval was granted through a standard expedited pathway. The application number for this approval is BLA761365.

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FDA

Marketing authorisation holder: ASTELLAS
Status: approved

Vyloy 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 Vyloy approved in United States?

Yes. FDA authorised it on 18 October 2024; FDA has authorised it.

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

ASTELLAS holds the US marketing authorisation.