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Immune Deficiencies

FDA Grants Regenerative Medicine Advanced Therapy Designation to MB-107 Lentiviral Gene Therapy for X-Linked Severe Combined Immunodeficiency

NEW YORK and MEMPHIS, Tenn., Aug. 22, 2019 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (NASDAQ: MBIO) and St. Jude Children’s Research Hospital have announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted the Regenerative Medicine …

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ADMA Biologics Receives FDA Approval for License Transfers for Bivigam and Nabi-HB

RAMSEY, N.J. and BOCA RATON, Fla., July 08, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious …

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FDA Approves Grifols’ Xembify, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies

Barcelona, July 4, 2019.– Grifols (MCE:GRF, MCE:GRF.P NASDAQ:GRFS), 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 Drug Administration (FDA). Xembify® is used to treat primary immunodeficiencies. The FDA approval marks the culmination of an important …

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FDA Approves New Product Label for Octapharma’s Octaplas

HOBOKEN, N.J.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has approved a revised product label for Octapharma USA’s Octaplas™, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion. The new labeling provides the results of a post-marketing study on Octaplas™ that demonstrates the product’s safety, efficacy and tolerability in treating critically ill pediatric …

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FDA Approves ADMA Biologics’ Asceniv, a Novel Intravenous Immune Globulin

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 immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, …

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FDA Approves Leadiant’s Revcovi for the Treatment of ADA-SCID in Pediatric and Adult Patients

GAITHERSBURG, Md.–(BUSINESS WIRE)–Leadiant Biosciences, Inc. today announced that the Food and Drug Administration (FDA) has granted approval to Revcovi™ (elapegademase-lvlr) injection in the U.S. Revcovi is a new enzyme replacement therapy (ERT) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. “We are gratified …

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Enzyvant and Visikol Collaborate to Develop Innovative Digital Pathology Assay to Support RVT-802 Development

BASEL, Switzerland and WHITEHOUSE STATION, N.J., July 5, 2018 /PRNewswire/ — Enzyvant, a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases, today announced that it has formed a partnership with Visikol, a contract research organization focused on digital pathology and drug discovery. Under the terms of …

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Early Diagnosis Can Save Babies’ Lives: A Guide to Severe Combined Immunodeficiency Disease (SCID)

A new review provides guidance on a deadly, but rare, disease that is potentially curable if identified early. Severe combined immunodeficiency disease (SCID), known as the “bubble boy disease” in the 1970s, is treatable with a stem cell transplant, gene therapy and other treatments if identified at birth or soon …

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FDA Grants Breakthrough Therapy and Regenerative Advanced Therapy Designation to Enzyvant’s RVT-802

BASEL, Switzerland, April 17, 2017 /PRNewswire/ — Enzyvant, a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RVT-802, Enzyvant’s investigational tissue-based therapy for the treatment of complete DiGeorge Syndrome (cDGS), Breakthrough Therapy designation as …

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BPL’s Gammaplex Wins FDA Approval for Treatment of PI and CITP

ELSTREE, UK AND DURHAM, NC – FEBRUARY 7, 2017 – Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Gammaplex® 10% (immune globulin intravenous [human], 10% liquid) for the treatment of primary immunodeficiency (PI) and …

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