ADMA - ADMA Biologics gets label expansion for Bivigam in pediatric setting

2023-12-12 07:51:01 ET

ADMA Biologics ( NASDAQ: ADMA ) has received FDA approval for Bivigam for treating primary humoral immunodeficiency (PI) in patients aged 2 years and older.

"This expanded label for Bivigam allows ADMA to actively address the treatment needs of younger PI patients earlier in their treatment journey. In the periods ahead, we look forward to offering BIVIGAM as an FDA-approved treatment option for these pediatric PI patients," said Adam Grossman, president and chief executive officer of ADMA.

Bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of patients with PI. The FDA approval represents the final study report for the pediatric assessment as required in the post marketing commitment.

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