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.
FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones
The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…
FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients
The FDA has approved Truxima (rituximab-abbs), which is biosimilar to Rituxan (rituximab), for treating adults with CD20-positive, B-cell non-Hodgkin’s lymphoma…
FDA Update: Topical Plaque Psoriasis Treatment Approved; Dupilumab Will Receive FDA Priority Review
The FDA has approved halobetasol propionate lotion as a topical treatment for plaque psoriasis…
Rituximab Receives Label Update for ANCA-Associated Vasculitis
The FDA has approved an update for rituximab’s label, which will include safety and efficacy information for treating ANCA-associated vasculitis…
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