ADMA Biologics, Inc.

Rule Changes

Manufacturer of ASCENIV; commercial beneficiary of label expansion

For seven years, an immune therapy made from antibody-rich human plasma was available only to teenagers and adults. On May 4, 2026, the U.S. Food and Drug Administration extended ADMA Biologics' ASCENIV to children as young as two—closing a gap that left some of the most vulnerable pediatric patients dependent on off-label prescribing or alternative drugs.

Updated 3 hours ago