Novel Immunomodulator Gets Orphan Drug Status for Sarcoidosis
Results from a phase 1/2 showed that ATYR1923 was safe and well tolerated.
Immune Disorders
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.
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.
Jakafi Approved for Chronic Graft-vs-Host Disease
The approval was based on data from the phase 3 REACH3 study which included 329 patients.
Ruzurgi Tablets Recalled Due to Yeast, Mold, Bacterial Contamination
The tablets may be contaminated with yeast, mold, and aerobic bacterial.
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…
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.
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