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ADMA Biologics Says FDA Approves ASCENIV Supplemental BLA

ADMA
Healthcare & BiotechRegulation & LegislationProduct LaunchesCompany Fundamentals

ADMA Biologics said the FDA approved its supplemental BLA for ASCENIV under section 351(a) of the Public Health Service Act. The approval is a positive regulatory step for the company’s biologics portfolio and supports commercialization of the product. The news is favorable for ADMA but appears incremental rather than market-moving at the sector level.

Analysis

ADMA Biologics said the FDA approved its supplemental BLA for ASCENIV under section 351(a) of the Public Health Service Act. The approval is a positive regulatory step for the company’s biologics portfolio and supports commercialization of the product. The news is favorable for ADMA but appears incremental rather than market-moving at the sector level.

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