drugset
Drugs / Bivigam
last change Jun 2026 re-read 3 minutes ago

Bivigam

Protein / enzyme biologic

Investigated by
ADMA Biologics, Inc.

Trials 1

today NCT03164967 · Ph 4
20172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT03164967 Dec 2016 → Aug 2022 — ADMA Biologics, Inc. Completed No outcome recorded

Press releases naming this drug 15 releases

DateIssuerRelease
2024-03-11 ADMA Biologics, Inc. ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV™ & BIVIGAM® admabiologics.com ↗
2023-12-12 ADMA Biologics, Inc. ADMA Biologics Announces FDA Approval for BIVIGAM® in the Pediatric Patient Setting for Those 2 Years of Age and Older admabiologics.com ↗
2022-12-13 ADMA Biologics, Inc. ADMA Biologics Announces FDA Approval for Room Temperature Storage of ASCENIV™ & BIVIGAM® admabiologics.com ↗
2022-03-25 ADMA Biologics, Inc. ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months admabiologics.com ↗
2021-08-09 ADMA Biologics, Inc. ADMA Biologics Announces Commercial Availability of Expanded Vial Size Offerings for BIVIGAM® and NABI-HB® admabiologics.com ↗
2019-10-17 ADMA Biologics, Inc. ADMA Biologics Announces Publication of an Article Describing the Manufacturing Process Optimization for its Commercial Products BIVIGAM® and ASCENIV™ in the Peer Reviewed Journal Immunotherapy admabiologics.com ↗
2019-08-22 ADMA Biologics, Inc. ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM® admabiologics.com ↗
2019-07-08 ADMA Biologics, Inc. ADMA Biologics Receives FDA Approval for License Transfers for BIVIGAM® and Nabi-HB® admabiologics.com ↗
2019-05-10 ADMA Biologics, Inc. FDA Approves Prior Approval Supplement for BIVIGAM® admabiologics.com ↗
2019-01-07 ADMA Biologics, Inc. ADMA Biologics Submits Response and Provides Supplemental Information to FDA for BIVIGAM® Complete Response Letter admabiologics.com ↗
2018-12-20 ADMA Biologics, Inc. ADMA to Host Conference Call to Discuss Recent Regulatory Update on BIVIGAM® PAS Submissions admabiologics.com ↗
2018-12-19 ADMA Biologics, Inc. ADMA Biologics Provides Regulatory Update on BIVIGAM® PAS Submissions admabiologics.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Bivigam ClinicalTrials.gov intervention name — accepted as the source's own label NCT03164967 ↗
Action Restore “requiring intravenous immunoglobulin G replacement” PMID 42218742 ↗ Jun 2026
Modality Protein / enzyme biologic “total immunoglobulin G (IgG) PK of Immune Globulin Intravenous [Human], 10% Liquid [IVIG]” PMID 42218742 ↗ Jun 2026
Route Intravenous “Serum IgG PK of IVIG following intravenous infusion” PMID 42218742 ↗ Jun 2026