Jakafi Approved for Chronic Graft-vs-Host Disease
The approval was based on data from the phase 3 REACH3 study which included 329 patients.
Immune Disorders
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
Abatacept Gets Priority Review for Moderate to Severe Acute Graft vs Host Disease
The supplemental Biologics License Application is supported by data from the phase 2 ABA2 trial (ClinicalTrials.gov Identifier: NCT01743131) and real world evidence from a registry trial.
New Vial Sizes for Bivigam, Nabi-HB Now Available
The new vial sizes are currently in stock and commercially available in the US.
Aviptadil Gets Orphan Drug Status for Sarcoidosis
RLF-100 (aviptadil) is an inhaled, synthetic formulation of vasoactive intestinal peptide (VIP) for the treatment of sarcoidosis.
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…
Octagam 10% Approved for Adult Dermatomyositis
The approval was based on data from the ProDERM study, which evaluated the efficacy and safety of Octagam 10% in 95 adults with dermatomyositis.
Prograf Approved to Prevent Organ Rejection in Lung Transplantation
The approval was based on an observational study using real-world data collected on all lung transplants in the US.
Rezurock Approved for Chronic Graft-vs-Host Disease
The approval was based on data from a phase 2 trial that evaluated Rezurock in 65 patients with chronic GVHD who received 2 to 5 prior lines of systemic therapy.
