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In a press release announcing RiVives approval, FDA Commissioner Robert Califf stated the regulators commitment to making naloxone accessible and encouraged other manufacturers of these products to discuss potential nonprescription development programs with the FDA

MARCH was a 26-week, randomized, placebo-controlled (PBO), Phase 3 trial of maralixibat (MRX), an ileal bile acid transporter (IBAT) inhibitor, that achieved its primary and key secondary endpoints of pruritus and sBA reduction for individuals across the broadest range of PFIC types studied