FDA — authorised 12 October 2017
- Application: BLA761049
- Marketing authorisation holder: EMD SERONO INC
- Indication: Labeling
- Status: approved
FDA authorised Bavencio on 12 October 2017
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 October 2017.
EMD SERONO INC holds the US marketing authorisation.