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.

The company presented positive data from a Phase III pivotal trial during the American Burn Association virtual annual meeting.

Vant deal, discovery platforms help Japanese firm build out pipeline before it faces the first expiries for its top seller.