FDA Grants Breakthrough Designation for Wayrilz to Treat Autoimmune Hemolytic Anemia

The U.S. Food and Drug Administration has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, reversible Bruton’s tyrosine kinase inhibitor, for the treatment of patients with warm autoimmune hemolytic anemia.

Vaccine Against SARS Virus Family Enters Human Clinical Trials

A vaccine candidate called GBP511 that builds upon a self-assembling nanoparticle technology has begun human clinical testing in Australia.

FDA Fast Tracks Gamgertamig for ITP

FDA has granted fast track designation to gamgertamig (OM336) for the treatment of immune thrombocytopenia and cold and warm autoimmune hemolytic anemia.

Breast Cancer Vaccine Study Shows Positive Results

A clinical tria that evaluated an alpha-lactalbumin (aLA) vaccine demonstrated an immune response in 74 percent of patients who presently have or are at high risk for triple-negative breast cancer.

Study Identifies First Case of Spontaneous Genetic Correction in Severe Immunodeficiency

A study has identified, for the first time, a case of spontaneous correction of a genetic mutation in a patient with CD137 deficiency, a rare immunodeficiency that causes vulnerability to Epstein–Barr virus infection.

GAMMAGARD LIQUID ERC Is Now Available in the U.S.

GAMMAGARD LIQUID ERC (immune globulin infusion [human]) with less than or equal to 2 µg/mL IgA in a 10% solution, by prescription, is now available in the U.S.

Novartis’ Ianalumab Granted FDA Breakthrough Therapy Designation for Sjögren’s Disease

The U.S. Food and Drug Administration has granted breakthrough therapy designation to ianalumab for Sjögren’s disease.

Scientists Develop Inhalabale Nanotherapy to Fight Melanoma Resistant to Checkpoint Inhibitors

Researchers have developed an inhalable nanotherapy called BEAT (Bispecific Exosome Activator of T Cells) that can activate the immune system against cancers resistant to current checkpoint inhibitor therapies.

Human Trials Begin for Fentanyl Vaccine to Prevent Overdoses

A vaccine that blocks the effects of fentanyl, including overdoses, is scheduled for Phase I human trials in the Netherlands in early 2026 to assess its safety.

HHS Doubles AI-Backed Cancer Research Funding

The U.S. Department of Health and Human Services has doubled funding for its Childhood Cancer Data Initiative at the National Institutes of Health