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Articles tagged with "U.S. Food and Drug Administration (FDA)"

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.

ACR Executive Committee Holds Meetings with Heads of FDA, CMS

From the College  |  May 17, 2025

As in past administrations, members of the Executive Committee scheduled meetings with leaders of the Food & Drug Administration and Centers for Medicare & Medicaid Services to discuss ACR policy priorities and agency agendas.

Cilnidipine Receives Orphan Drug Status to Treat Systemic Sclerosis

Michele B. Kaufman, PharmD, BCGP  |  May 9, 2025

Based on research showing improved signs and symptoms of systemic sclerosis in patients taking cilnidipine vs. placebo, the FDA granted orphan drug designation for the agent.

Nipocalimab Receives Breakthrough Therapy Status for Sjögren’s Disease

Michele B. Kaufman, PharmD, BCGP  |  May 9, 2025

Nipocalimab, an investigational monoclonal antibody that blocks FcRn and reduces levels of circulating immunoglobulin G (IgG) antibodies, has received the FDA’s breakthrough therapy designation for the treatment of Sjögren’s disease.

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.

mRNA CAR T Cell Therapy Receives FDA’s Rare Pediatric Designation to Treat Juvenile Dermatomyositis

Michele B. Kaufman, PharmD, BCGP  |  January 30, 2025

FDA has granted Descartes-08, an mRNA chimeric antigen receptor T cell therapy, a rare pediatric disease designation for the treatment of juvenile dermatomyositis.

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 Officials Discuss Extrapolation & Confusion Around Pediatric Therapies

Thomas R. Collins  |  December 3, 2024

A session at ACR Convergence 2024 addressed several recent drug approvals in pediatric rheumatology and a safety update for IL-1/IL-6 inhibitors.

FDA Accepts New Drug Application for Suzetrigine, a Non-Opioid Analgesic

Michele B. Kaufman, PharmD, BCGP  |  September 16, 2024

The FDA accepted a new drug application for suzetrigine, a non-opioid analgesic, based on the results from clinical trials in patients with neuropathy and those post-surgery.

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