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Primary Immunodeficiency Syndrome News
FDA Approves Yimmugo (immune globulin intravenous, human-dira) to Treat Primary Immunodeficiencies
Barcelona, Spain, June 17, 2024 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest, a Grifols Group company, ha...
FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
YOGIN, South Korea, Dec. 17, 2023 /PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved Alyglo (immune globulin intravenous, h...
ADMA Biologics Announces FDA Approval for Bivigam in the Pediatric Patient Setting for Those 2 Years of Age and Older
Signifies the Successful Fulfillment of Bivigam’s Post Marketing Commitments as Part of the Original BLA Approval Expanded Label in the U.S. Now Includes Pediatric PI Patients 2 Years of Age and O...
CSL Behring Receives FDA Approval for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe
KING OF PRUSSIA, Pa., April 18, 2023 /PRNewswire/ – Global biotechnology leader CSL Behring today announced the U.S. Food and Drug Administration (FDA) approved a 50mL/10gm prefilled syringe for...
Takeda Receives FDA Approval to Expand the Use of Hyqvia to Treat Primary Immunodeficiency in Children
CAMBRIDGE, Mass.--(BUSINESS WIRE) April 11, 2023 --Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license...
FDA Approves Xembify (immune globulin subcutaneous) for Primary Immunodeficiencies
Barcelona, July 4, 2019.- Grifols, a leading global producer of plasma-derived medicines, announced today that Xembify, its new 20% subcutaneous immunoglobulin, has been approved by the U.S. Food and...
ADMA Announces It Will Reintroduce Bivigam Into the Market
RAMSEY, N.J. and BOCA RATON, Fla., May 10, 2019 (GLOBE NEWSWIRE) – ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty im...
FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency
RAMSEY, N.J. and BOCA RATON, Fla., April 01, 2019 (GLOBE NEWSWIRE) – ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty ...
Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency
Lexington, Mass. – September 14, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the United States Food and Drug Administration (FDA) has granted approval for Cuvitru [Immune Globulin Sub...
FDA Medwatch Alert: Bivigam Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed
[Posted 04/05/2013] ISSUE: During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration Date: March 31, 2014) of Bivigam Immune Globulin Intravenous ...
FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid
DREIEICH, Germany and BOCA RATON, Fla., Dec. 20, 2012 /PRNewswire/ – Biotest AG announced today that Biotest Pharmaceuticals Corporation received approval for Bivigam for the treatment of patients...
Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid for Patients with Primary Immunodeficiency
DEERFIELD, Ill.--(BUSINESS WIRE)--Jul 25, 2011 - Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous administration of Gammagard...
Talecris Biotherapeutics Receives FDA Approval for Gamunex-C
RESEARCH TRIANGLE PARK , N.C., Oct. 14 /PRNewswire-FirstCall/ – Talecris Biotherapeutics (Nasdaq: TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune...
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