FDA Fast Tracks Immunotherapy for HER2-Positive Breast Cancer Recurrence
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.
IVIG Reduces Infections Following BsAB Therapies in Multiple Myeloma Patients
A recent study showed treatment with intravenous immune globulin following infection from BCMA therapies yielded a 67 percent decrease in infections in patients with multiple myeloma.
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.
New Documentary Gives Women with Hemophilia a Voice
A new documentary film titled “Dismissed,” which was premiered at the National Bleeding Disorders Foundation’s Bleeding Disorders Conference in Aurora, Colo., features the lived experiences of five women with hemophilia.
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.
Study Finds Lymphoma Accelerates Aging of Immune Cells and Tissues
A new study led by a team of researchers at Moffitt Cancer Center reveals lymphoma can accelerate the biological aging of the immune system and other tissues, providing new insight into how cancer reshapes the body beyond tumor growth.
FDA Approves Implantable Device to Treat RA Patients
SetPoint System, a neuroimmune modulation device, has been approved by the U.S. Food and Drug Administration to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease-modifying anti-rheumatic drugs.
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.