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.
Study Finds No Connection Between Antibiotic Use and Autoimmune Disease in Children
A groundbreaking retrospective cohort analysis of more than four million children offers compelling evidence that there is no significant association between early antibiotic exposure and heightened risk of autoimmune diseases in children.
FDA May Revoke Pfizer’s COVID-19 Vaccine for Young, Healthy Children
The U.S. Food and Drug Administration may revoke Pfizer-BioNTech’s emergency use authorization for its COVID-19 vaccine, Comirnaty, for children ages 6 months through 4 years.
FDA Requires Major Changes to Opioid Pain Medical Labeling
The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use.
Study Shows Seeing Sick Faces May Activate the Immune System
A recent study shows that participants who see sick-looking faces in virtual reality exhibit changes in brain activity related to personal space monitoring and threat detection, as well as an increase in the activity of certain immune cells in the blood.
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.