FDA — authorised 28 April 2023
- Application: BLA761097
- Marketing authorisation holder: REGENERON PHARMACEUTICALS
- Indication: Efficacy
- Status: approved
🇺🇸 Libtayo in United States
FDA authorised Libtayo on 28 April 2023
Marketing authorisation
Libtayo 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 Libtayo approved in United States?
Yes. FDA authorised it on 28 April 2023.
Who is the marketing authorisation holder for Libtayo in United States?
REGENERON PHARMACEUTICALS holds the US marketing authorisation.