---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-012605"
form_type: "8-K"
ticker: "ADMA"
cik: "0001368514"
company_name: "ADMA BIOLOGICS, INC."
filed_at: "2024-03-11T23:59:59+00:00"
generated_at: "2026-06-04T23:43:07.010059+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA approves extended room temperature storage for ADMA's ASCENIV and BIVIGAM

## Summary
- FDA approved supplemental BLAs to allow 4-week room temperature (25°C) storage at any time during the 36-month shelf life.
- Previously, room temperature storage was only allowed during the first 24 months; now applies to all existing and future lots.
- CEO Adam Grossman stated the approval enables reaching customers previously limited by cold chain constraints.
- Both products are immediately commercially available to U.S. healthcare providers.
- Approval expected to improve inventory management and product administration for providers.

## SEC filing metadata
- accession: 0001140361-24-012605
- form_type: 8-K
- ticker: ADMA
- cik: 0001368514
- company_name: ADMA BIOLOGICS, INC.
- filed_at: 2024-03-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1368514/000114036124012605/0001140361-24-012605-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1368514/000114036124012605/ef20023792_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-012605
- JSON: https://secwatch.observer/filing/0001140361-24-012605.json
- Plain text: https://secwatch.observer/filing/0001140361-24-012605.txt

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