To speed the development of tocilizumab to treat giant cell arteritis (GCA), the FDA designated it as a breakthrough therapy earlier this month…
Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis
Abaloparatide for Osteoporosis Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily…
FDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug Safety Labeling Changes Database
Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…
Adalimumab-atto, Biosimilar to Humira, Receives FDA Approval
Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…
FDA Approves Ustekinumab for Crohn’s Disease
(Reuters)—Johnson & Johnson says on Monday that the U.S. Food and Drug Administration approved the company’s psoriasis drug, ustekinumab (Stelara), for use in adults with Crohn’s disease. The drug is approved in the U.S. to treat plaque psoriasis and a type of arthritis associated with psoriasis. Crohn’s is a chronic inflammatory condition in the gastrointestinal…
FDA Approves Adalimumab-atto, a Biosimilar of Humira
WASHINGTON (Reuters)—The U.S. Food and Drug Administration on Friday approved a cheaper, biosimilar version of AbbVie’s top-selling arthritis drug, adalimumab (Humira). The drug, adalimumab-atto (Amjevita), is made by biotechnology company Amgen Inc. and was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions. Amjevita is the fourth biosimilar to be approved…
Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…
Abaloparatide Promising for Osteoporosis; NICE Draft Guidelines Include Secukinumab for Ankylosing Spondylitis
In a clinical trial, subcutaneous abaloparatide has proved effective in treating postmenopausal women with osteoporosis. Also in the U.K., draft guidelines for treating ankylosing spondylitis will recommend the use of secukinumab…
FDA Approves Etanercept-szzs Biosimilar
Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…
U.S. FDA Approves Biosimilar to Etanercept
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no…
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