US CRL For Astellas's Zolbetuximab Over Manufacturing Issues
Revised Approval Timeline Unclear
Astellas has received a US CRL for it's potential first-in-class drug zolbetuximab, after questions over a manufacturing line came up after an FDA site inspection and could not be answered by the original 12 January PDUFA date. The Japanese firm will refile the application after resolving the issues, but the likely revised timeline is not yet clear.
