Results from a Phase 3 study showed ixekizumab significantly improved the signs and symptoms of non-radiographic axial spondyloarthritis in patients…
IV Meloxicam Stalls at FDA; Plus Health Canada Approves Risankizumab for Plaque Psoriasis
In a second response letter, the FDA has cited the onset and duration of intravenous meloxicam, a non-opioid pain treatment, as concerns that it fails to meet prescriber expectations…
FDA Approves Drug for Lambert-Eaton Myasthenic Syndrome
(Reuters)—Jacobus Pharmaceutical Co Inc on Monday won U.S. approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. The drug, Ruzurgi (amifampridine), was approved for use in patients ages 6–17, the according to the U.S. Food and Drug Administration (FDA). Lambert-Eaton myasthenic syndrome (LEMS), which affects about three people…
FDA Approves Certolizumab Pegol for Treating Non-Radiographic Axial SpA
Certolizumab pegol is now FDA approved to treat adults with active non-radiographic axial spondyloarthritis…
FDA Approves New Osteoporosis Medication
Romosozumab-aqqg has been approved in the U.S. for treating postmenopausal women with osteoporosis at high risk of fracture…
FDA Greenlights Osteoporosis Drug for Postmenopausal Women
(Reuters)—The U.S. Food and Drug Administration says it has approved Amgen’s osteoporosis treatment for postmenopausal women who are at high risk of fracture. Evenity (romosozumab-aqqg), developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. Romosozumab-aqqg belongs to a new…
U.S. FDA Chief Gottlieb Resigns
WASHINGTON (Reuters)—U.S. Food and Drug Administration (FDA) Chief Scott Gottlieb said he plans to step down in a month, calling into question how the agency will handle critical issues, such as e-cigarette use among teens and efforts to increase competition in prescription drugs. The U.S. Department of Health and Human Services (HHS), which oversees the…
Upadacitinib at the FDA
Upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor, which recently completed phase 3 clinical trials for treating patients with moderate to severe rheumatoid arthritis (RA). In late 2018, AbbVie Inc. submitted a New Drug Application to the U.S. Food and Drug Administration, as well as a marketing authorization application to the European Medicines Agency,…
Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone
Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…
FDA Advisory Committee Votes in Favor of Romosozumab Approval
An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.
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