FDA ends 2023 on high note for GI: Ulcerative colitis pipeline teeming with new approvals healio.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healio.com Daily Mail and Mail on Sunday newspapers.
The NDA submission was supported by positive data from the phase 3 PHALCON-NERD-301 study and has been assigned a standard 10-month review with a PDUFA target action date of July 19, 2024.
November’s Gastroenterology Month in Review features an FDA approval, the discontinuation of a phase 3 clinical program, and news about Clostridioides difficile testing and risk factors.