The U.S. FDA will give Roche’s experimental therapy for spinal muscular atrophy an expedited review and will decide on approval within six months, If approved, Roche’s risdiplam would be the third SMA therapy to reach market in the U.S., following approvals for Biogen’s Spinraza and Novartis’ Zolgensma. Less than three years ago, there were no FDA-approved medicines for SMA, a rare disease that is the most common genetic cause of infant mortality. According to Roche, the regulatory agency is expected to make a decision by May 24, 2020. Learn More