When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
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Our infographic shows the various routes that the 60 novel agents took to approval, from Real-Time Oncology Review to Qualified Infectious Disease Product designation.
The latest news about applications under FDA review, from the Pink Sheet’s US FDA Performance Tracker
Following Orphazyme’s disappointment in the US regarding its investigational drug for an ultrarare disease, the company has said it will need more time to address outstanding issues raised by EU reviewers about the same medicine.