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.
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 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…
U.S. FDA Warns Against Using Hydroxychloroquine for COVID-19
(Reuters)—On April, the U.S. Food and Drug Administration (FDA) cautioned against the use of malaria drug hydroxychloroquine (HCQ) in COVID-19 patients even as President Donald Trump, who has touted it as a “game changer,” advocated for an additional review. The drug, first approved in 1955, provided no benefit and potentially higher risk of death for…
FDA Cautions Slower Drug Review Activity Due to Staff Reallocation for COVID-19
(Reuters)—On April 16, the U.S. Food & Drug Administration (FDA) cautioned that with a lot of its staff allocated to the coronavirus crisis, it may not be able to sustain its current level of timely reviews and approvals of marketing applications. FDA says it was working to ensure that the drug programs continue to see…
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