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

ADMA BIOLOGICS, INC.

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.

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