---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-23-057341"
form_type: "8-K"
ticker: "ADMA"
cik: "0001368514"
company_name: "ADMA BIOLOGICS, INC."
filed_at: "2023-12-12T23:59:59+00:00"
generated_at: "2026-06-07T14:04:37.429560+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001140361-23-057341
- form_type: 8-K
- ticker: ADMA
- cik: 0001368514
- company_name: ADMA BIOLOGICS, INC.
- filed_at: 2023-12-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1368514/000114036123057341/0001140361-23-057341-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1368514/000114036123057341/ef20016477_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-23-057341
- JSON: https://secwatch.observer/filing/0001140361-23-057341.json
- Plain text: https://secwatch.observer/filing/0001140361-23-057341.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.