Medicines Articles
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.
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 (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.
The U.S. Food and Drug Administration has granted breakthrough therapy designation to ianalumab for Sjögren’s disease.
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.
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.
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.
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.
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.
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.
A recent study shows the use of hormone therapy in postmenopausal women was associated with a significantly higher incidence and risk of autoimmune diseases.
FDA has accepted a supplemental new drug application for leniolisib to treat activated phosphoinositide 3-kinase delta syndrome, or APDS, in children aged 4 to 11 years.