Repligen Imaging Aid SecreFlo May Provide Pancreatitis Patients An Endoscopy Alternative

A second read of Phase III data revealed statistically significant improvement in MRIs of pancreatitis patients for Repligen’s imaging aid SecreFlo. That finding will be tested by FDA’s Gastrointestinal Drugs Advisory Committee May 31.

The clinical evidence behind Repligen Corp.’s NDA for its imaging agent SecreFlo will likely face tough scrutiny when it goes before an FDA advisory committee in May, as the application was based on a re-read of data from a Phase III trial.

On May 31, FDA’s Gastrointestinal Drugs Advisory Committee is set to take up the NDA for use of SecreFlo with...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA Performance Tracker

More from Regulatory Trackers