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.”