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The US Food and Drug Administration (FDA) approved a subcutaneous delivery formulation of methotrex­ate (Otrexup; Antares Pharma) for once-weekly self-administration of the drug, with an easy-to-use, single-dose, disposable auto injector. This new subcutaneous formulation is indicated for adults with severe active rheumatoid arthritis (RA) whose disease has an inadequate response to or who are intolerant of an adequate trial of first-line therapy for RA, includ­ing nonsteroidal anti-inflammatory agents, as well as for children with active polyarticular juvenile idiopathic arthritis (pJIA). The FDA also approved Otrexup for adults for the symptomatic control of severe recalcitrant and disabling psoriasis that is not adequately responsive to other forms of therapy.
The US Food and Drug Administration (FDA) approved the first anti–interleukin (IL)-12 and anti–IL-23, ustekinumab (Stelara; Janssen Biotech), alone or in combination with methotrexate, for the treatment of adult patients aged ≥18 years with active psoriatic arthritis.
The US Food and Drug Administration (FDA) approved a new indication for golimumab (Simponi Aria for infusion; Janssen Biotech) for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA) to be used in combination with methotrexate. Only 2 months earlier, the FDA approved golimumab injection for the treatment of patients with ulcerative colitis.
The US Food and Drug Administration (FDA) approved canakinumab (Ilaris; Novartis) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged ≥2 years.
The FDA approved a new indication for the tumor necrosis factor inhibitor golimumab (Simponi injection; Janssen Biotech) for the treatment of adults with moderate-to-severe ulcerative colitis that is refractory to previous treatment or that requires continuous corticosteroid therapy.
In November 2012, the US Food and Drug Administration (FDA) approved tofacitinib (Xeljanz; Pfizer) for adult patients with moderate-to-severe rheumatoid arthritis (RA) who do not adequately respond to or are intolerant of methotrexate.
The US Food and Drug Admin­istration (FDA) has approved an expanded indication for tocilizumab (Actemra; Genentech), a humanized in­terleukin-6 receptor–inhibiting mon­o­clonal antibody, for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) who have had an inadequate response to therapy with ≥1 disease-modifying anti­rheumatic drugs (DMARDs).
The FDA has approved a new in­dication for adalimumab (Humira; Abbott Laboratories) for the treatment of moderate-to-severe ulcerative colitis in adults, to control ulcerative colitis when immunosuppressant medicines, such as corticosteroids, azathioprine, and 6-mercaptopurine, have not worked.
The FDA approved a new indication for the subcutaneous RANK li­gand inhibitor denosumab (Prolia) for the treatment of bone mass loss in men with osteoporosis who are at high risk for fracture. Denosumab, 60 mg, is administered as a single injection by a healthcare provider every 6 months.
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