Rinvoq Approved for Active Ankylosing Spondylitis
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
Diagnosis & Disease Information
Ultomiris Approved for Generalized Myasthenia Gravis
The approval was based on data from a phase 3 study that included 175 adults with generalized myasthenia gravis who were not previously treated with a complement inhibitor.
Nitrosamine Impurity Detected in Certain Lots of Orphenadrine Citrate ER Tablets
Orphenadrine citrate ER tablet is indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
EULAR Recommendations for CV Risk Management in Rheumatic and Musculoskeletal Diseases
A EULAR task force recently developed recommendations for the management of cardiovascular risk in patients with rheumatic and musculoskeletal diseases, including gout, lupus, and systemic sclerosis.
Pegloticase Plus Methotrexate Gets Priority Review for Uncontrolled Gout
The sBLA submission is supported by data from the phase 4 MIRROR trial.
FDA to Review Abrilada for Interchangeability With Humira
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
Risdiplam Gets Prority Review for Presymptomatic Spinal Muscular Atrophy
Risdiplam is a survival motor neuron 2 splicing modifier.
Skyrizi Gets FDA Approval for Psoriatic Arthritis
The approval was based on data from 2 pivotal phase 3 studies, which compared Skyrizi to placebo in adults with active PsA who had an inadequate response or were intolerant to biologic therapy and/or nonbiologic DMARDs.
Horizon Seeks Approval of Pegloticase Plus Methotrexate for Uncontrolled Gout
The sBLA submission is supported by data from the phase 4 MIRROR trial.
Antisense Oligonucleotide Fast Tracked for Myotubular and Centronuclear Myopathies
The Company is currently evaluating DYN101 in the phase 1/2 UNITE-CNM trial in patients 16 years of age and older with CNM caused by mutations in the MTM1 or DNM2 gene.
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