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
Read the original firm alert โ Friday, October 23, 2026