Linaclotide regulatory update

Ironwood said FDA told the company that it will not schedule an advisory committee meeting to discuss an NDA for linaclotide, which is under review for chronic constipation and irritable bowel syndrome with constipation (IBS-C). Details were not disclosed. The PDUFA date is in June; an exact date is not disclosed. The partners will co-commercialize the guanylate cyclase C ( GCC; GUCY2C) agonist in the U.S. ...