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FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier for spinal muscular atrophy (SMA). Risdiplam is designed to increase and sustain SMN protein levels both throughout the central nervous system and peripheral tissu