Bad Times For Breakthrough Drugs Targeting Chemo Complications; Submissions From BMS, Merck

The latest news about applications under FDA review, from the Pink Sheet’s US FDA Performance Tracker

brick wall falling down (Alamy)
Recent review setbacks are a reminder that breakthrough designations involve breaking things. • Source: Alamy

Two complete response letters from the US Food and Drug Administration were revealed in the waning days of November. Interestingly, both CRLs went to products holding breakthrough therapy designations in the same general field of supportive care for patients undergoing chemotherapy.

BeyondSpring Inc.’s plinabulin and Fennec Pharmaceuticals Inc.’s Pedmark are the latest members of a small group that has been expanding in the last two years: BTD products with CRLs

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