🇺🇸 Kymriah in United States

Kymriah (TISAGENLECLEUCEL) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Kymriah 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 Kymriah approved in United States?

Yes. FDA has authorised it.

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

Novartis Pharmaceuticals Corporation is the originator. The local marketing authorisation holder may differ — check the official source linked above.