FDA — authorised 4 September 2014
- Marketing authorisation holder: MERCK SHARP DOHME
- Status: approved
🇺🇸 Keytruda in United States
FDA authorised Keytruda on 4 September 2014
Marketing authorisations
FDA — authorised 4 September 2014
- Application: BLA125514
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: KEYTRUDA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 21 November 2025
- Application: BLA761467
- Marketing authorisation holder: MERCK SHARP DOHME
- Indication: Efficacy
- Status: approved
The FDA approved Keytruda, a medication developed by MERCK SHARP DOHME, on 21 November 2025. The approval was granted under the standard expedited pathway. The application number for this approval is BLA761467. The marketing authorisation holder for Keytruda is MERCK SHARP DOHME.
Keytruda 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 Keytruda approved in United States?
Yes. FDA authorised it on 4 September 2014; FDA authorised it on 4 September 2014; FDA authorised it on 21 November 2025.
Who is the marketing authorisation holder for Keytruda in United States?
MERCK SHARP DOHME holds the US marketing authorisation.