प्राथमिक स्रोत रिकॉर्ड
निर्णायकFDA लेबल अपडेट
ADMA Biologics: FDA ने ASCENIV के लेबल को ≥2 वर्ष के बाल PI रोगियों तक विस्तारित किया
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+.
मुख्य तथ्य
- फाइल किया गया
- 4 मई 2026, 11:05 am
- घटना
- FDA लेबल अपडेट
- दिशा
- सकारात्मक
- कंपनी
ADMAADMA Biologics- संपत्ति
- ASCENIV
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
स्रोत का अंश
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