FDA — authorised 15 June 2020
- Application: BLA761109
- Marketing authorisation holder: ELI LILLY AND CO
- Status: supplemented
FDA authorised Lyumjev on 15 June 2020
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 June 2020; FDA has authorised it.
ELI LILLY AND CO holds the US marketing authorisation.