FDA Expands Approval for Recombinant VWF

The U.S. Food and Drug Administration has expanded the approval of recombinant von Willebrand factor, marketed as Vonvendi.

FDA Approves LEQEMBI IQLIK to Treat Early Alzheimer’s Disease

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.

FDA Approves First BTK Inhibitor for ITP

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.

Nektar Therapeutics’ Rezpegaldesleukin Approved by FDA to Treat Alopecia Areata

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.

FDA Approves EMPAVELI as the First Treatment for C3G or Primary IC-MPGN

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.

FDA Accelerates Approval for Rare Kidney Disease

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.

FDA Approves Immune Checkpoint Inhibitor for Head and Neck Cancer

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.

FDA Approves New FcRN Blocker to Treat Generalized Myasthenia Gravis

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

Uplizna Approved to Treat IgG4-Related Disease

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.

Triglyceride Drug Approved to Treat Adults with FCS

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.