ADMA BIOLOGICS, INC.
ASCENIV
primary humoral immunodeficiency (PI)
Resolved
154days ago
Approval decision · May 4, 2026
What's at stake
A final FDA approval decision on ASCENIV for primary humoral immunodeficiency (PI) is expected May 4, 2026.
Primary source
· SEC 8-K
verified 3mo ago
“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™.”