ARTICLE | Company News
FDA pushes back PDUFA for Bavarian's smallpox vaccine
March 14, 2019 11:53 PM UTC
Bavarian Nordic said FDA extended by three months its review of a BLA for its smallpox vaccine, MVA-BN. The new PDUFA date is in September.
Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) said the agency needs more time "due the amount of data submitted during the review phase."...
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