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Industry News
Apremilast Tablets Approved by FDA as a Generic for Psoriatic Arthritis
February 17, 2021
The drug is commonly used to treat diseases such as psoriatic arthritis, Behcet’s Syndrome, and plaque psoriasis.
FDA Approves First Oral Therapy Voclosporin for Lupus Nephritis
January 25, 2021
Voclosporin (LUPKYNIS), in combination with an existing immunosuppressive therapy regimen, works to safely and effectively treat adult patients with lupus nephritis.
ACR Takes Steps to Close the Gap in Lupus Care
October 30, 2020
The American College of Rheumatology has launched a project designed to resolve inequities in care for patients with systemic lupus erythematosus, a condition that is two or three times more common among ethnic minorities. In this interview, S. Sam Lim, M.D., MPH, chair of ACR’s Collaborative Initiatives Special Committee, tells us more about the project.
Dapagliflozin Earns Breakthrough Therapy Designation for Chronic Kidney Disease
October 02, 2020
Dapagliflozin (Farxiga, AstraZeneca) has been granted breakthrough therapy designation by the U.S. Food and Drug Administration for patients with chronic kidney disease with and without type 2 diabetes. It is currently approved as a treatment to improve glycemic control in adults with type 2 diabetes.
Golimumab Approved for Pediatric Forms of Juvenile Arthritis and Psoriatic Arthritis
September 30, 2020
Golimumab (Simponi Aria, Janssen/J&J) has been approved by the U.S. Food and Drug Administration for two pediatric conditions:active pediatric juvenile idiopathic arthritis (JIA) and active pediatric psoriatic arthritis.
Tofacitinib Approved for Juvenile Arthritis
September 30, 2020
The U.S. Food and Drug Administration has approved tofacitinib Xeljanz, Pfizer) for the treatment of children and adolescents two years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
New Treatment Approved for Devic’s Disease
August 18, 2020
The U.S. FDA has approved a third treatment for the rare autoimmune condition, Devic's disease. The condition is associated with blindness and paralysis and often coexists with other rheumatic conditions, such as lupus and rheumatoid arthritis.
New RA Biosimilar Approved for U.S. Market
July 14, 2020
The U.S. FDA has approved the sixth biosimilar to Humira, adalimumab-FKJP (Hulio), which will be available in the United States in 2023 for rheumatoid arthritis, psoriatic arthritis, psoriasis, juvenile arthritis and other conditions.
FDA Approves Treatment for Still's Disease
July 14, 2020
The U.S. FDA has approved the first treatment for adult-onset Still's disease, a rare form of systemic juvenile idiopathic arthritis associated with high fever, arthritis and rash.
Guselkumab Approved for Psoriatic Arthritis
July 14, 2020
The U.S. Food and Drug Administration has approved the first IL-23 inhibitor for moderate to severe psoriatic arthritis. The newly approved treatment, guselkumab, has been shown to improve the signs and symptoms of fatigue associated with PsA.