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Articles tagged with "FDA approval"

Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability

Michele B. Kaufman, PharmD, BCGP  |  June 18, 2025

Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.

FDA Approves Upadacitinib for GCA

Michele B. Kaufman, PharmD, BCGP  |  June 16, 2025

Supported by data in patients with new-onset and relapsing giant cell arteritis (GCA), the FDA approved upadacitinib for the treatment of adults with GCA.

FDA Approvals: Lupus Nephritis

Michele B. Kaufman, PharmD, BCGP  |  May 31, 2025

Lupus nephritis is one of the leading causes of mortality for patients with systemic lupus erythematosus (SLE), and patients with both SLE and end-stage renal disease have standardized mortality ratios more than 60 times that of patients with SLE with normal kidney function.1 The good news: Rheumatologists now have not one, but two approved options…

Belimumab Promising for Children with Lupus Nephritis

Michele B. Kaufman, PharmD, BCGP  |  May 31, 2025

In late July 2022, the U.S. Food & Drug Administration (FDA) approved belimumab (Benlysta) for the treatment of children with active lupus nephritis aged 5 to 17 years old receiving standard therapy.1 Despite recent advances in treatment options for patients with systemic lupus erythematosus (SLE), those with kidney involvement may develop endstage renal disease and…

FDA Approves Suzetrigine (VX-548), a Non-Opioid Analgesic

Michele B. Kaufman, PharmD, BCGP  |  April 29, 2025

Based on research in post-surgery patients, the FDA approved suzetrigine, a non-opioid analgesic, for the treatment moderate to severe, acute pain in adults.

FDA Approval Sought for 2 Pediatric Indications for Guselkumab

Michele B. Kaufman, PharmD, BCGP  |  February 11, 2025

The FDA is reviewing supplemental biologics license applications for guselkumab to treat children with juvenile psoriatic arthritis and moderate to severe plaque psoriasis.

FDA Approves Bimekizumab-bkzx (Bimzelx) for 3 New Rheumatic Indications

Michele B. Kaufman, PharmD, BCGP  |  December 30, 2024

The FDA has approved bimekizumab-bkzx for the treatment of adults with psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

FDA Approves 2 Upadacitinib Formulations for Children with pJIA & PsA

Michele B. Kaufman, PharmD, BCGP  |  August 13, 2024

Upadacitinib, as a tablet and oral solution, is now FDA approved to treat children age 2 years and older with active polyarticular juvenile idiopathic arthritis or psoriatic arthritis.

FDA Approves Sarilumab for pJIA

Michele B. Kaufman, PharmD, BCGP  |  July 29, 2024

The FDA has granted sarilumab its first pediatric indication, approving the agent to treat active, polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kgs.

FDA Issues Boxed Warning for Denosumab & Approves a Generic NSAID

Michele B. Kaufman, PharmD, BCGP  |  February 27, 2024

In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.

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