FDA — authorised 19 May 2023
- Marketing authorisation holder: GENMAB US, INC.
- Status: approved
🇺🇸 Epkinly in United States
FDA authorised Epkinly on 19 May 2023
Marketing authorisations
FDA — authorised 19 May 2023
- Application: BLA761324
- Marketing authorisation holder: GENMAB US, INC.
- Local brand name: EPKINLY
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
The FDA approved Epkinly, a product of GENMAB US, INC., for its approved indication. This approval was granted on 18 November 2025, following a standard expedited pathway. The application number for this approval is BLA761324.
Epkinly 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 Epkinly approved in United States?
Yes. FDA authorised it on 19 May 2023; FDA authorised it on 19 May 2023.
Who is the marketing authorisation holder for Epkinly in United States?
GENMAB US, INC. holds the US marketing authorisation.