🇺🇸 TECVAYLI in United States

FDA authorised TECVAYLI on 25 October 2022

Marketing authorisation

FDA — authorised 25 October 2022

Application: BLA761291
Marketing authorisation holder: JANSSEN BIOTECH
Local brand name: TECVAYLI
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved TECVAYLI, a product of Janssen Biotech, on 2 December 2024. The approval was granted under the standard expedited pathway with the application number BLA761291. TECVAYLI is indicated for a Risk Evaluation and Mitigation Strategy (REMS) programme, but the specific indication is not reported.

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TECVAYLI 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 TECVAYLI approved in United States?

Yes. FDA authorised it on 25 October 2022.

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

JANSSEN BIOTECH holds the US marketing authorisation.