Thursday, June 10, 2021

-=Ocugen (OCGN) to pursue a BLA path in the US for its COVID-19 vaccine candidate

  • Co announced that upon FDA recommendation, it will pursue submission of a biologics license application (BLA) for COVAXIN, its COVID-19 vaccine candidate, and will no longer pursue an Emergency Use Authorization. Co is in discussions with the FDA to understand the additional information required to support a BLA submission and anticipates that data from an additional clinical trial will be required; co states that while this will extend its timeline, it remains committed to bringing COVAXIN to the US.




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