Immune Deficiencies

FDA Grants Mustang Bio’s MB-207 Rare Pediatric Disease Designation for Treatment of X-linked Severe Combined Immunodeficiency in Previously Transplanted Patients

WORCESTER, Mass., Aug. 31, 2020 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that the U.S. Food and Drug Administration …

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Kedrion and Kamada Announce Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin Met its Primary Objective

REHOVOT, Israel and FORT LEE, N.J., Aug. 19, 2020 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ & TASE: KMDA) and Kedrion Biopharma, two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, today announced results from a U.S. post-marketing pediatric trial of KEDRAB® (Rabies Immune Globulin [Human]). The study represents the first …

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Mustang Bio’s MB-107 Granted Rare Pediatric Disease Designation from the FDA for Treatment of X-linked Severe Combined Immunodeficiency

WORCESTER, Mass., Aug. 17, 2020 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that the U.S. Food and Drug Administration …

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Octapharma Reports Positive Data from Octagam Usage in Critically Ill COVID-19 Patients

LACHEN, Switzerland–(BUSINESS WIRE)–Topline results from a retrospective study in 93 critically ill COVID-19 patients have become available. The data shows that IVIG treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival, in critically ill COVID-19 patients, when compared to a …

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CSL Behring and Seattle Children’s Research Institute to Advance Gene Therapy Treatments for Primary Immunodeficiency Diseases

SEATTLE and KING of PRUSSIA, Pa., June 2, 2020 /PRNewswire/ — Seattle Children’s Research Institute, one of the top pediatric research institutions in the world, and global biotechnology leader CSL Behring announced a strategic alliance to develop stem cell gene therapies for primary immunodeficiency diseases. Initially, the alliance will focus …

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FDA Grants Breakthrough Therapy Designation for X4 Pharmaceuticals’ Mavorixafor for Treatment of WHIM Syndrome

CAMBRIDGE, Mass.–(BUSINESS WIRE)–X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for mavorixafor (X4P-001) for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, …

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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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