zolbetuximab

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Astellas claims EU okay for first claudin 18.2 cancer drug

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.

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Astellas refiles CLDN 18.2 cancer drug after FDA knockback

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

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Japan clears first CLDN18.2 drug, Astellas’ Vyloy

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

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FDA blocks Astellas’ Claudin cancer drug over manufacturing

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

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FDA grants Priority Review of Astellas’ zolbetuximab BLA

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

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