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

FDA Approves Risankizumab, Adds Stronger Warning to Sleep Medications

Michele B. Kaufman, PharmD, BCGP  |  May 29, 2019

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

Michele B. Kaufman, PharmD, BCGP  |  May 21, 2019

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

Michele B. Kaufman, PharmD, BCGP  |  May 14, 2019

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 Staff  |  May 8, 2019

(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

Michele B. Kaufman, PharmD, BCGP  |  April 30, 2019

Certolizumab pegol is now FDA approved to treat adults with active non-radiographic axial spondyloarthritis…

FDA Approves New Osteoporosis Medication

Michele B. Kaufman, PharmD, BCGP  |  April 23, 2019

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

Saumya Joseph  |  April 11, 2019

(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

Michele B. Kaufman, PharmD, BCGP  |  March 12, 2019

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…

Safety Risk with Higher Dose Tofacitnib

Michele B. Kaufman, PharmD, BCGP  |  March 6, 2019

According to the FDA, an ongoing safety trial found higher dose tofacitinib increased the risks of pulmonary embolism and death in RA patients…

Tainted Research Repeatedly Re-Used to Assess Drug Effectiveness

Gene Emery  |  March 5, 2019

(Reuters Health)—A new study shows how fake news—specifically, information about scientific research that may be tainted by fraud—keeps getting spread through the medical literature, misleading doctors about the safety and effectiveness of the drugs they prescribe. At issue is the failure of medical journals to flag research that’s been identified by the U.S. Food and…

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