Results from multiple phase 3 clinical trails have led to the FDA approval of upadacitinib to treat patients with moderate to severe active RA…
FDA Approves AbbVie’s New Rheumatoid Arthritis Drug
(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…
FDA Approves Risankizumab, Adds Stronger Warning to Sleep Medications
The FDA has approved rizankixumab to treat adults with plaque psoriasis and added boxed warnings to sleep medications…
Ixekizumab Promising for Non-Radiographic Axial SpA; Plus FDA Approves Belimumab for Pediatric Lupus
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…
FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare
The FDA has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related and other death in RA patients…
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