Kaitlin Kestenberg

Rule Changes

As of May 2026: Oversaw pediatric post-marketing study and sBLA filing

For seven years, an immune therapy made from antibody-rich human plasma was available only to teenagers and adults. On May 4, 2026, the FDA extended ADMA's ASCENIV to children as young as two, ending the reliance on off-label or alternatives.

Updated May 31