Enzyvant Therapeutics, Inc.
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Latest From Enzyvant Therapeutics, Inc.
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.
Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
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