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In the next six months, the FDA expects to issue decisions on three novel therapies.
On April 23, 2026, the US Food and Drug Administration approved gene therapy Otarmeni (lunsotogene parvec-cwha) for the treatment of genetic hearing loss.
According to Mesoblast’s press release on April 7, 2026, “This study represents an important step forward in potentially addressing the inflammatory component of DMD, a major driver of disease progression.”
A new phase 1b study by Biogen is now evaluating the drug salanersen in patients with SMA who have already received the gene therapy Zolgensma.
On December 18, 2024, the FDA approved Ryoncil (Remestemcel-L-rknd) as the first and only off-the-shelf allogeneic bone marrow-derived mesenchymal stromal cell therapy for children who are two months old to adolescents with steroid-refractory acute graft-versus-host disease (SR-aGVHD).