The U.S. Food and Drug Administration (FDA) in late March approved the biologic medication certolizumab pegol (Cimzia), a tumor necrosis factor (TNF) inhibitor, to treat a newly defined condition called non-radiographic axial spondyloarthritis (nr-axSpA). Continue reading FDA Approves First Drug for Newly Defined Spinal Condition
With several years gone by since the last drug for osteoarthritis (OA) was approved, the 27 million Americans with OA are ready to hear Yes when it comes to new therapies and diagnostic tests for OA.
Fortunately, this past May, Arthritis Foundation met with Janet Woodcock, the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) and her colleagues. A representative from the Center for Biologics Evaluation and Research (CBER) also attended the meeting. The goal of the meeting was to discuss how the organizations can work together to design and implement new approaches to clinical trials that will accelerate the improvement of health outcomes for people with OA.