Industry News

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.

FDA Approves Device for Low Back Pain

July 02, 2020

The U.S. Food and Drug Administration has granted pre-market approval to Mainstay Medical Holdings for the production of an implantable neurostimulator for chronic low back pain.

Secukinumab Approved for Active Non-radiographic Axial Spondyloarthritis

June 19, 2020

Secukinumab, an IL-17a inhibitor currently approved in the United States for moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis, has been approved by the U.S. Food and Drug Administration for the treatment of active non-radiographic axial spondyloarthritis.