Medicines Articles
FDA has accepted a supplemental new drug application for leniolisib to treat activated phosphoinositide 3-kinase delta syndrome, or APDS, in children aged 4 to 11 years.
The U.S. Food and Drug Administration has approved Libtayo (cemiplimab-rwlc) for the adjuvant, or postsurgical, treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
The U.S. Food and Drug Administration has granted fast track designation for Greenwich LifeSciences’ lead immunotherapy candidate GLSI-100 in HLA-A*02–positive, HER2-positive breast cancer patients who have completed standard HER2-targeted therapy.
The U.S. Food and Drug Administration has expanded the approval of recombinant von Willebrand factor, marketed as Vonvendi.
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for once weekly lecanemab-irmb subcutaneous injection (LEQEMBI IQLIK, pronounced “I Click”) for maintenance dosing.
The U.S. Food and Drug Administration has approved Sanofi’s Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
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.