🇺🇸 Romvimza in United States

FDA authorised Romvimza on 14 February 2025

Marketing authorisations

FDA — authorised 14 February 2025

Application: NDA219304
Marketing authorisation holder: DECIPHERA PHARMS
Local brand name: ROMVIMZA
Indication: CAPSULE — ORAL
Status: approved

The FDA granted marketing authorisation to Romvimza, a drug developed by Deciphera Pharms, on 12 December 2025. This authorisation was granted through the standard expedited pathway. The approved indication for Romvimza is listed in its labelling, but the specific indication is not specified in the available data.

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FDA

Marketing authorisation holder: DECIPHERA PHARMS
Status: approved

Romvimza 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 Romvimza approved in United States?

Yes. FDA authorised it on 14 February 2025; FDA has authorised it.

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

DECIPHERA PHARMS holds the US marketing authorisation.