Keytruda Biosimilar FDA Review: FYB206 BLA Accepted
FDA has accepted the Zydus and Formycon FYB206 BLA for review, the first publicly announced Keytruda biosimilar filing. Decision possible in Q3 2027.
Zydus Saroglitazar Phase 3 Trial: New PBC Subgroup Data
Zydus saroglitazar Phase 3 trial: post hoc EPICS-III data show 60.7% vs 0% (US) and 55.1% vs 13.5% (non-US) response in PBC. Small groups; FDA review continues.