Johnson & Johnson’s anti-FcRn antibody nipocalimab is the first investigational therapy to be granted breakthrough therapy designation by the U.S. Food and Drug Administration as a treatment for adults with moderate-to-severe Sjögren’s disease.
A population-based study conducted by researchers from the Republic of Korea found a significantly higher risk of developing autoimmune and autoinflammatory conditions, such as rheumatoid arthritis (RA), lupus, Crohn’s disease, and alopecia, among individuals who had COVID-19, with risks particularly elevated for those with severe cases, Delta variant infections and those who were unvaccinated.
New research suggests autoantibodies in the nasal cavity may predict the severity of COVID-19 disease.
A new study indicates intravenous immun globulin (IVIG) therapy can reduce symptom severity for patients with autoimmune gastrointestinal dysmotility (AGID), also known as gastroparesis.
An mRNA vaccine has entered human trials as a treatment for lung cancer. Unlike traditional cancer vaccines such as the HPV vaccine, BNT116 is a therapeutic cancer vaccine designed to reduce tumor growth in patients with cancer or prevent its recurrence.
The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies).
The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter combination COVID-19 and influenza test, the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, outside of emergency use.
FDA has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARSCoV-2.
The U.S. Department of Health and Human Services (HHS) has negotiated lower prices for 10 of the most expensive and widely used drugs covered under Medicare, which is expected to save the Medicare program $6 billion in the first year and reduce out-of-pocket costs for beneficiaries by $1.5 billion.
An investigational, individualized neoantigen therapy, with personalized encoded mRNA, has demonstrated potential to enable patients’ immune systems to target cells that cause cancer.
The U.S. Food and Drug Administration (FDA) has approved the first needle-free alternative to the EpiPen.
FDA has approved Octapharma USA's Fibryga (fibrinogen [human] lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency.