Drugs / Asceniv™
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | ASCENIV | primary humoral immunodeficiency | — | “the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a)” admabiologics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05070455 | Sep 2022 → Mar 2023 | immunodeficiency disease | ADMA Biologics, Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-04 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older admabiologics.com ↗ |
| 2025-11-05 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Third Quarter 2025 Financial Results and Provides Business Update admabiologics.com ↗
Positive, Statistically Significant Real-World Health Outcomes Demonstrated for ASCENIV™ |
| 2025-04-28 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process admabiologics.com ↗
today announced U.S. FDA approval of its innovative yield enhancement production process. |
| 2025-01-13 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces Preliminary Full Year 2024 Revenue and Provides Business Update admabiologics.com ↗
PAS Submitted to the FDA for Approval of Innovative Yield Enhancement Production Process; Potential Regulatory Approval Anticipated Mid-2025 |
| 2024-03-11 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV™ & BIVIGAM® admabiologics.com ↗
The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM. |
| 2022-12-13 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approval for Room Temperature Storage of ASCENIV™ & BIVIGAM® admabiologics.com ↗
FDA approvals for both ASCENIV and BIVIGAM provide for room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf life |
| 2022-03-25 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months admabiologics.com ↗ |
| 2021-10-22 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data Presented at the 2021 ISIRV-WHO Conference admabiologics.com ↗
The abstract and poster presentation detailed the use of ASCENIV TM, a novel intravenous immune globulin (IGIV) human-slra, as concomitant therapy in a 70-year-old African American male with a history of bronchiectasis who presented with severe respiratory viral disease and confirmed COVID-19 infection. |
| 2021-10-04 | ADMA Biologics, Inc. | Results ADMA Biologics Announces the Presentation of Real-World Experience in the Management of Respiratory Syncytial Virus (RSV) Presented at IDWeek 2021 admabiologics.com ↗
The two cases presented detailed scenarios in which ASCENIV administration demonstrated notable benefits in the clinical course of two children diagnosed with primary immunodeficiency (PI) and documented RSV infection. |
| 2021-01-26 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives Unique Permanent J-Code for ASCENIV™ admabiologics.com ↗
ADMA Biologics, Inc. (Nasdaq: ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the Centers for Medicare and Medicaid Services (CMS) has issued a permanent, product-specific J-code for ASCENIV™. |
| 2021-01-04 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives Unique Temporary C-Code and Pass-Through Payment Status for ASCENIV™ admabiologics.com ↗ |
| 2019-10-07 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data Presented at IDWeek 2019 admabiologics.com ↗
The poster detailed data obtained from the compassionate use of ASCENIV™ (formerly referred to as RI-002) in the treatment of Respiratory Syncytial Virus (“RSV”) infection in two immunocompromised children. |
| 2019-04-02 | ADMA Biologics, Inc. | Regulatory ADMA Receives Department of Health and Human Services U.S. License admabiologics.com ↗
The license covers the Boca Raton, FL manufacturing facility which has demonstrated compliance with FDA requirements as well as authorizes ADMA to manufacture and enter into interstate commerce with ASCENIV™. |
| 2019-04-01 | ADMA Biologics, Inc. | Regulatory FDA Approves ASCENIV™, a Novel Intravenous Immune Globulin admabiologics.com ↗ |
All press releases naming this drug 18 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asceniv | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05070455 ↗ |
| Route | Intravenous | “administered as an intravenous infusion” NCT05070455 ↗ |