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.
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.
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.
FDA Approves Expanded Label for Jascayd for PPF
Boehringer Ingelheim’s Jascayd (nerandomilast) has been given an expanded label by the U.S. Food and Drug Administration to include use in adults with progressive pulmonary fibrosis.
Lunsumio VELO Has Been Approved for R/R FL
FDA has approved CD20xCD3 bispecific Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome
The U.S. Food and Drug Administration has approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome.
FDA Approves VOYXACT to Treat Kidney Disease
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
KEYTRUDA and KEYTRUDA QLEX Approved to Treat Adults Patients with MIBC
The U.S. Food and Drug Administration has approved KEYTRUDA and KEYTRUDA QLEX in combination with Padcev, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.
Study Shows Hormone Therapy Is Linked to Autoimmune Disease
A recent study shows the use of hormone therapy in postmenopausal women was associated with a significantly higher incidence and risk of autoimmune diseases.