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Immune Deficiencies

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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Amgen and Immatics Partner To Develop Novel Bispecific Cancer Immunotherapies

THOUSAND OAKS, Calif. and TUEBINGEN, Germany, Jan. 9, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Immatics Biotechnologies GmbH, a leading company in the field of cancer immunotherapy, today announced a research collaboration and exclusive license agreement to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancers. The collaboration will combine Immatics’ world-leading …

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FDA Approves Shire’s Cuvitru for Treatment of 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 Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. CUVITRU is a treatment for …

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Kedrion Biopharma Expands Immunoglobulin Therapies Portfolio, Gains Commercial Rights in the U.S. to BIVIGAM®, a Recently Approved IGIV Brand

Kedrion Biopharma Inc., established in the U.S. market in 2011, is an emerging player in the rare disease arena The Company aims to build business rapidly through ongoing organic growth of its brand portfolio and strategic partnerships with other industry leaders Gaining rights to commercialize BIVIGAM® [Immune Globulin Intravenous (Human), …

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