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ADMA

ADMA Biologics Says FDA Approves ASCENIV Supplemental BLA

May 04, 2026 — 07:29 am EDT

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(RTTNews) - Biopharmaceutical company ADMA Biologics, Inc. (ADMA) announced Monday the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act for ASCENIV.

The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment.

Additionally, the approval provides for a revision of ASCENIVs prescribing information to expand the primary humoral immunodeficiency (PI) indication to pediatric patients two years of age and older.

Previously, the indication for ASCENIV was restricted to PI patients aged 12 years and older.

This expanded label for ASCENIV allows ADMA to actively address the treatment needs of younger PI and immune compromised patients earlier in their treatment journey.

In Monday's pre-market trading, ADMA is trading on the Nasdaq at $10.70, up $0.18 or 1.71 percent.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.