Medicines Articles
The U.S. Food and Drug Administration (FDA) has granted fast track designation to Nektar Therapeutics’ rezpegaldesleukin to treat alopecia areata (AA) in adult and paediatric patients aged 12 years and older who weigh at least 40 kilograms and are living with severe-to-very severe cases of the autoimmune disease.
The U.S. Food and Drug Administration has approved Apellis Pharmaceuticals’ EMPAVELI (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria.
The U.S. Food and Drug Administration has granted accelerated approval for Novartis’ Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥1) as determined by an FDA-approved test.
Johnson & Johnson has received U.S. Food and Drug Administration (FDA) approval for IMAAVY (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis
Amgen’s UPLIZNA has been approved by the U.S. Food and Drug Administration as the first and only treatment for adults living with Immunoglobulin G4-related disease.
Tryngolza (olezarsen) has been approved by the U.S. Food and Drug Administration to be used with diet to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome.
The U.S. Food and Drug Administration has approved Vertex Pharmaceutical’s Journavx (suzetrigine), a new type of prescription pain medication for adults to treat moderate to severe acute pain.
Celltrion’s Avtozma (tocilizumabanoh), a biosimilar to Actemra (tocilizumab), in both intravenous (IV)and subcutaneous (SC) formulations, has been approved by the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration (FDA) has approved a new type of antibiotic to treat urinary tract infections (UTIs).
Remestemcel-L, a new treatment for children ages 2 months and older with steroid-refractory acute graft-versus-host disease, has been approved by the U.S. Food and Drug Administration.
Celltrion has received U.S. Food and Drug Administration approval for its autoimmune disease treatment drug Steqeyma, a biosimilar of Johnson & Johnson’s Stelara (ustekinumab).