原始来源记录
决策级FDA 说明书更新
ADMA Biologics：FDA扩大ASCENIV标签至≥2岁儿科PI患者
FDA批准sBLA，取消先前年龄限制，现允许ASCENIV用于两岁及以上PI患者。扩大后的标签履行了上市后儿科研究承诺，并将目标患者人群从12岁以上扩大至2岁以上。
关键事实
来源摘录
EX-99.1 2 ef20072196_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV TM to Include Pediatric Immune Compromised Patients Two Years of Age and Older RAMSEY, N.J. and BOCA RATON, Fla., May 4, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced 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 mark