New Drug Applications

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

Written by David Miller

BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (TSE…Original Article

About the author

David Miller

a pharmacist, a tech enthusiastic, who explored the Internet to gather all latest information pharma, biotech, healthcare and other related industries.

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