Xembify Approved to Treat Primary Humoral Immunodeficiency
The approval was based on a prospective, open label, single arm, multicenter clinical trial that evaluated the safety and efficacy of Xembify compared with Gamunex-C.
Miscellaneous Immune Disorders
Rituxan Gets Priority Review for Pediatric Granulomatosis With Polyangiitis and Microscopic Polyangiitis
The FDA has accepted for Priority Review the supplemental BLA for Rituxan for use in combination with glucocorticoids for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children ≥2 years old.
FDA Accepts BLA for Tissue Based Regenerative Tx for Pediatric Congenital Athymia
The FDA has accepted for Priority Review the Biologics License Application for RVT-802 (Enzyvant), an investigational tissue-based regenerative therapy for pediatric congenital athymia.
Ruzurgi Approved for Pediatric Patients With Lambert-Eaton Myasthenic Syndrome
The FDA has approved Ruzurgi (amifampridine; Jacobus Pharmaceutical) for the treatment of Lambert-Eaton myasthenic syndrome in patients 6 to <17 years of age.
Is There Evidence to Support Kombucha Health Claims in Humans?
According to the results of a systematic review, there is a lack of evidence supporting the potential health benefits of kombucha, a fermented tea beverage, in humans.
Asceniv Approved for Primary Humoral Immunodeficiency in Adolescents, Adults
ADMA Biologics announced that the FDA has approved Asceniv (immune globulin intravenous [human] – slra) 10% Liquid for the treatment of primary humoral immunodeficiency disease (PIDD) in patients aged ≥12 years.
Investigational Treatment for Farber Disease Gets Fast Track, Rare Pediatric Disease Designations
Enzyvant announced that the Food and Drug Administration (FDA) has granted RVT-801 both Rare Pediatric Disease and Fast Track designations for Farber disease.
New Drug Product: Firdapse
This slideshow reviews drug information for Firdapse. Click here for the complete Firdapse monograph.
Report Details Case of Hydrochlorothiazide-Induced Lupus
Based on our finding, hydrochlorothiazide should be considered a possible offending agent when a patient presents with symptoms suspicious of drug induced lupus,” the study authors concluded.
Baricitinib Gets Fast Track Status for Systemic Lupus Erythematosus
Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
