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.
Researchers Develop New Dental Floss Needle-Free Flu Vaccine
In a proof-of-concept study, researchers at Texas Tech University successfully vaccinated mice against influenza by cleaning their teeth with dental floss coated with inactive flu viruses.
Takeda’s New Devices for Hyqvia Infusion Can Reduce Preparation Steps By Up to One-Half
The U.S. Food and Drug Administration has granted 510(k) clearance to Takeda’s HyHub and HyHub Duo for patients 17 years of age and older that allow HYQVIA [immune globulin infusion (human), 10% with recombinant human hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting.
Researchers Develop mRNA Vaccine That Stimulates Immune Response Against Cancer Tumors
Scientists at the University of Florida have developed an experimental mRNA vaccine that, when combined with standard immunotherapy drugs known as immune checkpoint inhibitors, produced a strong antitumor effect in mice, which could lead to a new way of treating cancer without relying solely on surgery, radiation or chemotherapy.
Early Childhood Exposure to Aluminum- Absorbed Vaccines Poses No Risks
A recent study shows early childhood exposure to aluminum-adsorbed vaccines is not associated with an increased risk for autoimmune, atopic or allergic, or neurodevelopmental disorders.
FDA Grants Full Approval for Spikevax in Children at Increased Risk of Disease
The U.S. Food and Drug Administration (FDA) has granted full approval for Moderna’s Spikevax (mRNA-1273) COVID vaccine in children 6 months through 11 years who are at an increased risk of the disease.
Personalized Melanoma Vaccine Elicits Strong Immune Response
Results of a Dana-Farber Cancer Institute-initiated Phase I clinical trial for patients with melanoma show that an updated formula and delivery of the NeoVax personalized cancer vaccine called NeoVaxMI is safe, feasible and improves the vaccine-specific immune response compared to previous trials of the platform.
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.