– Approval based on data from the randomized, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional Ocrevus dosing regimen – – Shorter infusion time will further improve the ...
The approval was based on data from the phase 3b ENSEMBLE PLUS study that compared the frequency and severity of infusion-related reactions for a 2-hour Ocrevus infusion time to the previously ...
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 approved a ...