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
Miscellaneous Immune Disorders
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.
Saphnelo Approved for Systemic Lupus Erythematosus
The Food and Drug Administration (FDA) has approved Saphnelo (anifrolumab-fnia) for the treatment of adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Type I interferons (IFNs) play a role in the pathogenesis of systemic lupus erythematosus (SLE). Anifrolumab-fnia, a human immunoglobulin G1 kappa monoclonal antibody, binds to subunit 1 of…
Drug-Induced Immunosuppression Examined in US Adults
Drug-induced immunosuppression, particularly from oral corticosteroids, may limit response to COVID-19 vaccine
Gene Therapy Promising for SCID Due to ADA Deficiency
High overall, event-free survival seen at 24 and 36 months for severe combined immunodeficiency due to ADA deficiency
