Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

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.

Recent applications for approval also include another DMD therapy, another hemophilia B gene therapy, and a new antibiotic.