The EU has followed Japan and GB in approving Astellas' first-to-market claudin 18.2-targeted therapy Vyloy, clearing it for gastric and gastroesophageal junction (GEJ) cancer.
The US FDA has started a fresh review of Astellas' zolbetuximab, trying to become the first claudin (CLDN) 18.2-targeting drug to reach the US market, after turning it dow
Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment
Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug can
Astellas Pharma Inc has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review of its zolbetuximab Biologics License Application