Anavip Approval Expanded to Include Copperhead, Cottonmouth/Water Moccasin Envenomations
Anavip contains venom-specific F(ab’)2 fragments of immunoglobulin G that bind and neutralize venom toxins.
Hematologic Disorders
Novel Biologic for Chemotherapy-Induced Neutropenia Submitted to FDA
Ryzneuta, also known as F-627, is an investigational, recombinant fusion protein containing G-CSF at the amino terminal and human IgG2-Fc fragment at the carboxyl terminal.
FDA Approves Vyxeos for Secondary Acute Myeloid Leukemia in Pediatric Patients
The FDA has expanded the approval of Vyxeos® (daunorubicin and cytarabine; Jazz Pharmaceuticals) to include the treatment of patients aged 1 year and older with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Vadadustat NDA Submitted for Anemia Due to Chronic Kidney Disease
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
Pediatric Data Added to Octaplas, Fibryga Labeling
The updated labeling for Octaplas and fibryga includes new pediatric data.
Bisphosphonates May Treat Calciphylaxis in Kidney Transplant Recipients
Moderate to severe hyperparathyroidism after kidney transplantation may have predisposed 2 cases to calciphylaxis, according to investigators.
COVID-19 Antibodies Found in 1 in 5 US Blood Donations
Percentage of donations with antibodies has risen steadily over time, according to the Red Cross
Gene Therapy for Sickle Cell Did Not Cause Patient’s Leukemia
Bluebird Bio says it has not found evidence that its gene therapy caused the sickle cell patient’s leukemia
Trial of Gene Therapy for Sickle Cell Disease Halted
Two patients participating in the study developed cancer years after treatment
Ruxolitinib Gets Priority Review for Chronic Graft-vs-Host Disease
The sNDA submission is based on data from the multicenter, randomized, open-label phase 3 REACH3 study.
