ALPMF - Astellas Pharma's imaging agent an Orphan drug in the U.S
The FDA has designated Fast Track status to Astellas Pharma's (ALPMF) imaging agent ASP5354.The Fast Track Designation Program aims to expedite the development and review of potential treatments.ASP5354 is an optical imaging agent underdevelopment as a surgical adjunct to lessen the likelihood of iatrogenic ureteral injury during abdominal and pelvic surgeries such as colorectal or gynecologic surgeries.Phase 2 study is currently underway to evaluate the safety and efficacy of ASP5354 in patients undergoing colorectal surgery
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Astellas Pharma's imaging agent an Orphan drug in the U.S