FDA — authorised 25 October 2022
- Application: BLA761291
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: TECVAYLI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Teclistamab Monotherapy in United States
FDA authorised Teclistamab Monotherapy on 25 October 2022
Marketing authorisation
Teclistamab Monotherapy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Teclistamab Monotherapy approved in United States?
Yes. FDA authorised it on 25 October 2022.
Who is the marketing authorisation holder for Teclistamab Monotherapy in United States?
JANSSEN BIOTECH holds the US marketing authorisation.