FDA approves ADMA's BIVIGAM for pediatric PI patients aged 2 and older

ADMA BIOLOGICS, INC.

FDA approved supplemental BLA for BIVIGAM to treat primary humoral immunodeficiency (PI) in patients 2 years and older.
Prior indication restricted to PI patients aged 12 years and older; label expansion opens new pediatric segment.
Approval fulfills post-marketing commitment from original BLA; final pediatric study report completed.
CEO Adam Grossman stated expanded label allows treating younger PI patients earlier in their treatment journey.
ADMA will offer BIVIGAM as an FDA-approved option for pediatric PI patients aged 2+ immediately.

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