FDA Approves Room Temp Storage Conditions for Asceniv and Bivigam
The new room temperature storage condition for Asceniv and Bivigam is immediately effective.
Diagnosis & Disease Information
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.
Imbruvica Approved for Pediatric Patients With Chronic Graft-vs-Host Disease
The approval was based on data from a phase 1/2 trial that included patients 1 year to less than 22 years of age with cGVHD after failure of 1 or more lines of systemic therapy.
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.
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.
Ruzurgi Tablets Recalled Due to Yeast, Mold, Bacterial Contamination
The tablets may be contaminated with yeast, mold, and aerobic bacterial.
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…
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