ADMA Biologics：FDA 擴大 ASCENIV 標籤適用於 ≥2 歲的兒科 PI 患者

FDA 核准 sBLA，移除先前年齡限制，現允許 ASCENIV 用於兩歲及以上 PI 患者。此擴大標籤完成上市後兒科研究承諾，並將適用患者族群從 12 歲以上擴大至 2 歲以上。

關鍵事實

申報時間: 2026年5月4日上午11:05
事件: FDA 仿單更新
方向: 正面
公司: ADMAADMA Biologics
資產: ASCENIV
來源: SEC 8-K
可信度: 有出處

來源摘錄

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

SEC 8-K