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Articles tagged with "FDA"

FDA Approves Drug for Lambert-Eaton Myasthenic Syndrome

Reuters Staff  |  

(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 Greenlights Osteoporosis Drug for Postmenopausal Women

Saumya Joseph  |  

(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

Yasmeen Abutaleb  |  

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

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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,…