The first half of 2023 has already seen landmark FDA decisions in the gastroenterology space, including multiple first-in-class therapies along with two costly rejections that highlight persistent gaps in the GI drug armory.
Since April, the agency has approved several firsts in the GI field, including the first drug to treat functional constipation in children, the first oral microbiota biotherapeutic for recurrent C. difficile and the first oral product to treat moderately to severely active Crohn’s disease.