FDA — authorised 27 October 2015
- Marketing authorisation holder: AMGEN
- Status: approved
FDA authorised Imlygic on 27 October 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 27 October 2015.
AMGEN holds the US marketing authorisation.