1. Pink Sheet
  3. >>US FDA Performance Tracker

First Imaging Agent For Brain Tumor Surgery Gets US FDA Panel Backing

 
• By Brenda Sandburg

Advisory committee votes for approval of 5-ALA for real time detection and visualization of malignant tissue during glioma surgery; data shows improvement in tumor resection, but not on survival metrics.

FDA entrance sign 2016

NX Development Corp.'s imaging agent 5-ALA (5-aminolevulinic acid hydrochloride) won a unanimous vote for approval from FDA's Medical Imaging Drugs Advisory Committee as panel members found it would be a valuable tool for removal of malignant tissue during glioma surgery.

At a May 10 meeting, panel members voted 11-0 to recommend approval of the agent to facilitate the real-time detection and visualization of malignant tissue during glioma surgery.

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
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers