FDA Approves Celltrion’s Steqeyma to Treat Autoimmune Diseases
Celltrion has received U.S. Food and Drug Administration approval for its autoimmune disease treatment drug Steqeyma, a biosimilar of Johnson & Johnson’s Stelara (ustekinumab).
Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has granted fast track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1-based immune checkpoint inhibitors.
FDA Observes Serious Liver Injury After Treatment with Ocaliva
FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis with Ocaliva who did not have cirrhosis of the liver.
Trial Shows Experimental Cancer Drug Helped Reduce Risk of Death in Common Blood Cancer
Results of a trial of GSK’s experimental cancer drug Blenrep showed that the drug used in combination with other treatments reduced the risk of death by 42 percent in multiple myeloma, at or after first relapse, compared to an existing treatment.
COVID-19 Vaccine May Reduce Risk of Developing Long COVID
A new study published in the journal Vaccine, shows that receiving a COVID-19 vaccine could reduce the risk of developing long COVID if it’s administered five months before an infection.
FDA Approves YESINTEK to Treat Autoimmune Diseases
Biocon Biologics has received U.S. Food and Drug Administration (FDA) approval for YESINTEK, a monoclonal antibody for the treatment of autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Y
Study Reveals Best Time to Get RSV Vaccine During Pregnancy
New research led by investigators at Mass General Brigham suggests vaccination closer to 32 weeks of pregnancy, rather than the current guidelines of between 32 and 36 weeks, will better protect pregnant women’s newborns against respiratory syncitial virus (RSV).
Study Finds Link Between COVID-19 and Autoimmunity
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.
Nasal Swab May Predict Severity of COVID-19
New research suggests autoantibodies in the nasal cavity may predict the severity of COVID-19 disease.
IVIG Reduces Symptom Severity for AGID
A new study indicates intravenous immun globulin (IVIG) therapy can reduce symptom severity for patients with autoimmune gastrointestinal dysmotility (AGID), also known as gastroparesis.
