FDA’s October approvals include the first CLDN18.2 mAb

FDA approved six new medicines in October, including the U.S.’s first CLDN18.2-targeting cancer therapy, and expanded labels for five approved therapies. 

Astellas Pharma Inc. (Tokyo:4503) has followed up is Japan approval of CLDN18.2 mAb Vyloy zolbetuximab, which marked the first approval of a therapy against the target worldwide, with an approval in the U.S. At least 32 other CLDN18.2 therapies are in clinical studies...