The FDA is requiring all benzodiazepines to carry an updated boxed warning that addresses the risks of misuse, abuse and addiction associated with their use.
FDA Receives Upadacitinib Application for Ankylosing Spondylitis & Approves Tramadol Hydrochloride Oral Solution
In August, Abbvie submitted a new drug application for upadacitinib to treat ankylosing spondylitis. And in September, the FDA approved an oral solution of tramadol hydrochloride for pain.
U.S. & E.U. Differ on Filgotinib for RA
This summer, the FDA rejected a new drug application for filgotinib to treat RA in the U.S., but a European Medicines Agency committee issued a positive opinion, moving filgotinib closer to authorized use in the E.U.
ACR Leaders Discuss Hydroxychloroquine Issues with FDA Commissioner
The conversation with Stephen Hahn, MD, addressed challenges associated with hydroxychloroquine access during the COVID-19 public health emergency and handling patient concerns about potential cardiac side effects.
Guselkumab Approved for PsA
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
In June, the FDA approved secukinumab to treat non-radiographic axial spondyloarthritis after data from a clinical trial demonstrated its efficacy…
FDA Approves Tremfya (Guselkumab) for Adult Patients with Psoriatic Arthritis
HORSHAM, PA—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.1,2 Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)…
FDA Approves Canakinumab for Adult-Onset Still’s Disease
Canakinumab, an interleukin (IL) 1 blocker, can now be prescribed to treat patients with active Still’s disease and adult-onset Still’s disease (AOSD)…
FDA Approves Celecoxib in an Oral Solution
The FDA has approved a 25 mg/mL dose of an oral solution of celecoxib to treat adults with acute migraine…
2 Pediatric Indications Sought for Golimumab
The FDA is reviewing supplemental Biologics License Applications for golimumab to treat polyarticular JIA and juvenile PsA…
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