The 2021 novel approval count at the US FDA’s Center for Drug Evaluation and Research hit 37 with the approval of Takeda Pharmaceutical Co. Ltd.’s targeted oncology drug Exkivity, but a Pink Sheet analysis of user fee goal dates missed by the FDA suggests that number could have been higher by as many as seven novel agents – or that our list of complete response letters could have been longer. (See sidebar for related story.)
Janus kinase inhibitors continue make up no small share of the missed user fee goals, but a submission for a...