Goodwin ProcterยทFDA / LIFE SCIENCES REGULATORY

FDA Accepts Pembrolizumab Biosimilar BLA for Review

Formycon and Zydus say FDA accepted for review the BLA for FYB206, a pembrolizumab biosimilar, marking the first publicly announced acceptance for a KEYTRUDA biosimilar in the US.

fda-bla-acceptancepembrolizumab-biosimilarformyconzyduspd-1-oncologybiosimilar

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