Corporate News 09-Feb-24
Biocon receives Complete Response Letter for Biologics License Application
From USFDA
Biocon announced that the U.S. Food and Drug Administration (US FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for bBevacizumab. The CRL did not identify any outstanding scientific issues on the dossier and informs the need for the completion of a pre-approval inspection of the bBevacizumab manufacturing facility.
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