FDA Approves KERENDIA to Treat Chronic Kidney Disease Associated with Type 1 Diabetes in Adults
The U.S. Food and Drug Administration has approved KERENDIA (finerenone) for adults with chronic kidney disease associated with type 1 diabetes.
FDA Approves Lisraya to Treat Dermatomyositis
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets to treat dermatomyositis in adults.
FDA Approves Takeda’s Orzeyful to Treat Type 1 Narcolepsy
The U.S. Food and Drug Administration has approved Takeda’s Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults.
FDA Approves Drug to Treat Hunter Syndrome
Avlayah (tividenofusp alfa-eknm) has been FDA-approved to treat some individuals with Hunter Syndrome (Mucopolysaccharidosis type II or MPS II).
FDA Approves Veligrotug-vvze (Lumvoa) for Thyroid Eye Disease
The U.S. Food and Drug Administration has approved veligrotug-vvze (Lumvoa; Viridian Therapeutics) to treat thyroid eye disease.
FDA Approves Merck’s KEYTRUDA QLEX for Solid Tumor Indications
The U.S. Food and Drug Administration has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA (pembrolizumab).
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.
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.