FDA — authorised 25 October 2022
- Marketing authorisation holder: JANSSEN BIOTECH
- Status: approved
🇺🇸 Bcmaxcd3 in United States
FDA authorised Bcmaxcd3 on 25 October 2022
Marketing authorisations
FDA — authorised 2 December 2024
- Application: BLA761291
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: REMS
- Status: approved
The FDA approved Bcmaxcd3, developed by Janssen Biotech, for a Risk Evaluation and Mitigation Strategy (REMS) indication. The approval was granted on 2 December 2024, following a standard expedited pathway. The application number for this approval is BLA761291.
Bcmaxcd3 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 Bcmaxcd3 approved in United States?
Yes. FDA authorised it on 25 October 2022; FDA authorised it on 2 December 2024.
Who is the marketing authorisation holder for Bcmaxcd3 in United States?
JANSSEN BIOTECH holds the US marketing authorisation.