FDA needs more information to approve manufacturing changes to ADMA's Bivigam

ADMA Biologics Inc. (NASDAQ:ADMA) said FDA has issued a complete response letter to a prior approval supplement (PAS) reporting CMC changes to an approved BLA for Bivigam. The company dropped $1.92 (46%) to $2.29 on Dec. 20 after announcing the CRL after market close on Dec. 19.

ADMA said FDA requested additional manufacturing runs...