Health news
The Food and Drug Administration (FDA) has expanded the approval of Evrysdi® (risdiplam) to include infants less than 2 months of age with spinal muscular atrophy (SMA). Previously, the treatment was only approved for patients 2…
The Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to 1 or more tumor necrosis factor…
The Food and Drug Administration (FDA) has approved Ultomiris® (ravulizumab-cwvz) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The approval was based on data from a global,…
The Food and Drug Administration (FDA) has granted Orphan Drug designation to efzofitimod (ATYR1923) for the treatment of systemic sclerosis. Efzofitimod is a potential first-in-class selective modulator of neuropilin-2 that is designed to downregulate innate…
Sandoz is voluntarily recalling 13 lots of Orphenadrine Citrate 100mg extended-release (ER) tablets to the consumer level due to the presence of a nitrosamine impurity, NMOA or nitroso-orphenadrine, above the Food and Drug Administration’s (FDA)…
The European Alliance of Associations for Rheumatology (EULAR) released recommendations for the clinical management of cardiovascular (CV) risk in patients with rheumatic and musculoskeletal diseases (RMDs), including gout, vasculitis, systemic sclerosis (SSc), myositis, mixed connective…
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the use of pegloticase injection plus methotrexate for the treatment of uncontrolled gout. Pegloticase, a PEGylated uric…
The Food and Drug Administration (FDA) has accepted for review a supplemental application for Abrilada (adalimumab-afzb) seeking to establish the drug as an interchangeable biosimilar to Humira® (adalimumab). An interchangeable biosimilar refers to a biosimilar…
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for risdiplam for use in presymptomatic infants less than 2 months of age with spinal muscular atrophy (SMA).…
The Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA). Skyrizi is also indicated for the treatment of moderate to severe plaque psoriasis in adults…
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