Author name: admin22

EMA’s human medicines committee (CHMP) has concluded its review of the medicine Tavneos (avacopan) and has recommended that the medicine’s marketing authorisation in the European Union be revoked because its benefits are no longer proven to outweigh its risks. Tavneos is used to treat adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two …

EMA recommends revoking marketing authorisation for Tavneos Read More »

On June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free …

FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies Read More »

The FDA issued a revised draft guidance for industry titled, “Master Protocols for Drug and Biological Product Development,” along with an accompanying guidance snapshot and recap podcast episode. This revised draft guidance reflects FDA’s consideration of public comments on the previous draft guidance for industry of the same name issued on December 21, 2023, including the addition of …

FDA Publishes the Revised Draft Guidance Master Protocols for Drug and Biological Product Development Read More »

On June 22, the U.S. Food and Drug Administration (FDA) published the draft guidance entitled “Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials.” FDA seeks feedback on this guidance document.