FDA Extends Shelf Life of Immune Globulin Products Asceniv and Bivigam
The new expiration date for Asceniv and Bivigam is immediately effective and applies to all existing lots currently in the commercial supply chain and to future production.
Miscellaneous Immune Disorders
Jergens Moisturizer Recalled Due to Bacteria Risk
The Pluralibacter gergoviae pathogen is an ongoing problem for the cosmetics industry
Cutaquig Approved for Pediatric Patients With Primary Humoral Immunodeficiency
Cutaquig is a ready-to-use immune globulin solution for subcutaneous infusion.
Potential Safety Concern for Guillain-Barré Syndrome ID’d for Ad26.COV2.S
Based on preliminary findings for presumptive GBS, overall observed-to-expected rate ratio estimated to be 4.18 for 42-day window
Rethymic Approved for Pediatric Congenital Athymia
Rethymic is engineered human allogeneic thymus tissue designed to reconstitute the immune system in pediatric patients with congenital athymia.
Tavneos Approved for ANCA-Associated Vasculitis
The approval was based on data from the phase 3 ADVOCATE trial, which evaluated Tavneos in 330 adults with newly diagnosed or relapsed ANCA-associated vasculitis.
New Drug Product: Saphnelo
This slideshow shows drug information for Saphnelo. Click here for the complete Saphnelo monograph.
Ruzurgi Tablets Recalled Due to Yeast, Mold, Bacterial Contamination
The tablets may be contaminated with yeast, mold, and aerobic bacterial.
mRNA COVID-19 Vaccines Immunogenic in Immunosuppressed Patients
Titers of anti-S IgG lower for patients with chronic inflammatory disease receiving glucocorticoids or B-cell depletion therapy
New Vial Sizes for Bivigam, Nabi-HB Now Available
The new vial sizes are currently in stock and commercially available in the US.
