July 10, 2026
Drug Approvals
Tregzi™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) – New drug approval
June 30, 2026 - Orca Bio announced the FDA approval of Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (GVHD)-free survival, in the treatment of adults with hematological malignancies.
Drug Approvals
Trutakna™ (atacicept-vymj) – New drug approval
July 7, 2026 - Vera Therapeutics announced the FDA approval of Trutakna (atacicept-vymj), to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
Clinical Updates
Casgevy® (exagamglogene autotemcel) – Expanded indication
July 1, 2026 - Vertex announced the FDA approval of Casgevy (exagamglogene autotemcel), for the treatment of patients aged 2 years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β-thalassemia (TDT).
Clinical Updates
Xeomin® (incobotulinumtoxinA) – Expanded indication
June 26, 2026 - Merz Therapeutics announced the FDA approval of Xeomin (incobotulinumtoxinA), for the treatment of upper limb spasticity in patients 2 years of age and older.
Clinical Updates
Zoryve® (roflumilast) – Expanded indication
June 29, 2026 - Arcutis Biotherapeutics announced the FDA approval of Zoryve (roflumilast) cream 0.3%, for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older.