ADMA Biologics:FDAがASCENIVのラベルを2歳以上の小児PI患者に拡大

FDA approved the sBLA that removes the prior age restriction, now allowing ASCENIV use in PI patients two years of age and older. The expanded label fulfills the post-marketing pediatric study commitment and broadens the addressable patient population from age 12+ to age 2+.

主要事実

提出: 2026年5月4日 11:05
イベント: FDA添付文書の更新
方向: ポジティブ
企業: ADMAADMAバイオロジクス
アセット: ASCENIV
出典: SEC 8-K
信頼度: 出典あり

出典の抜粋

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