US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.

The European Medicines Agency has recommended against the pan-EU marketing approval of two new medicines, while three others received positive opinions on marketing authorization.

CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.

Companies from China single-handedly sponsored a total of eight Phase III clinical studies that included US sites in 2023 compared to six in 2022 - but the figure was still below the record of 11 in 2021.