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Articles tagged with "FDA approval"

FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira

U.S. Food & Drug Administration  |  October 19, 2021

On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…

FDA Grants Octapharma 7-Year Market Exclusivity for Octagam 10%

Michele B. Kaufman, PharmD, BCGP  |  September 15, 2021

The FDA has granted a seven-year marketing exclusivity for Octagam 10%, a 10% solution of a human intravenous immunoglobulin (IVIG) that treats adults with dermatomyositis.

FDA Approves IVIG to Treat Adults with Dermatomyositis

Michele B. Kaufman, PharmD, BCGP  |  August 17, 2021

In July, the FDA approved the use of Octagam 10%, an intravenous immunoglobulin solution, to treat dermatomyositis in adults after an international study demonstrated the treatment’s safety and efficacy.

AbbVie, Lilly Face New Delays in FDA Approval for Expanded Use of Janus Kinase Inhibitors

Natasha Yetman  |  July 26, 2021

(Reuters)—AbbVie Inc. and ELi Lilly & Co. are facing fresh delays in the approval of their respective rheumatoid arthritis (RA) drugs for treating the chronic skin disease eczema as the U.S. health regulator assesses the new class of treatment over safety concerns. The treatment, called Janus kinase inhibitors (jakinibs), blocks inflammation-causing enzymes known as Janus…

FDA Approves Tocilizumab to Treat Systemic Sclerosis-Associated ILD

Michele B. Kaufman, PharmD, BCGP  |  March 25, 2021

Subcutaneous tocilizumab is the first biologic agent approved by the FDA treat patients with systemic sclerosis-associated interstitial lung disease.

FDA Approves Belimumab & Voclosporin for Lupus Nephritis

Michele B. Kaufman, PharmD, BCGP  |  March 24, 2021

In December, the FDA approved belimumab, the first drug approved to treat lupus nephritis, an historic action that was rapidly followed in January by the approval of a second treatment for lupus nephritis, voclosporin.

FDA Approves New Rituximab Biosimilar & Anakinra to Treat a Rare Disease

Michele B. Kaufman, PharmD, BCGP  |  February 2, 2021

The FDA has approved anakinra to treat a rare autoinflammatory disease, deficiency of interleukin 1 receptor antagonist. The administration also approved a new rituximab biosimilar, Riabni, for multiple indications.

FDA Approves Golimumab for Patients with pJIA & Psoriatic Arthritis

Michele B. Kaufman, PharmD, BCGP  |  October 21, 2020

The FDA has approved golimumab for the treatment of pediatric patients with active polyarticular juvenile idiopathic arthritis or active psoriatic arthritis…

Guselkumab Approved for PsA

Michele B. Kaufman, PharmD, BCGP  |  August 6, 2020

Based on data from two clinical trials, the FDA has approved guselkumab to treat adult patients with active psoriatic arthritis…

FDA Approves Secukinumab for Non-Radiographic Axial Spondyloarthritis

Michele B. Kaufman, PharmD, BCGP  |  August 5, 2020

In June, the FDA approved secukinumab to treat non-radiographic axial spondyloarthritis after data from a clinical trial demonstrated its efficacy…

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