Tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis.
The prescribing information for Uloric (febuxostat; Takeda) is being updated to include a Boxed Warning regarding an increased risk of cardiovascular (CV) death and all-cause mortality in patients treated with the gout drug.
Tanezumab, an investigational subcutaneously-administered, non-opioid treatment, may benefit patients with moderate to severe chronic low back pain.
The FDA has accepted for Priority Review the New Drug Application for upadacitinib, an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis.
Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.
Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF).
In the Biologics License Application (BLA) resubmission, Amgen and UCB proposed to narrow the indication to treatment of osteoporosis in postmenopausal women at high risk of fracture.
Vascular EDS is the most severe subtype of Ehlers-Danlos syndrome where patients suffer from life-threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures.
The FDA has approved updated labeling for Rituxan to include information on follow up treatment for patients with GPA and MPA who have achieved disease control with induction therapy.
The approval was based on data from a randomized, double-masked, placebo-controlled study of 90 pediatric patients aged 2 to < 18 years with active JIA-associated non-infectious uveitis.
