🇺🇸 STEQEYMA in United States

FDA authorised STEQEYMA on 17 December 2024

Marketing authorisation

FDA — authorised 17 December 2024

Application: BLA761338
Marketing authorisation holder: CELLTRION, INC.
Local brand name: STEQEYMA
Indication: INJECTABLE — SUBCUTANEOUS
Status: approved

The FDA granted marketing authorisation to STEQEYMA, a product of CELLTRION, INC., on 28 April 2025. The marketing authorisation was granted under the standard expedited pathway. The approved indication for STEQEYMA is listed in its labelling.

Read official source →

STEQEYMA in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is STEQEYMA approved in United States?

Yes. FDA authorised it on 17 December 2024.

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

CELLTRION, INC. holds the US marketing authorisation.