Tags : Regulatory Applications

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02

Shots: The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21 The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of […]Read More