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.

China's Zai Lab and Everest are still pursuing profitability on the commercialization of in-licensed assets, while BioNova and others have already bowed out of the game.

Plus deals involving Novo Nordisk/Neomorph, Mabwell/Jiangsu Haibo, Alteogen/Merck & Co., Gilead/Biocytogen, AlphaGen/ARTBIO and XOMA/Kinnate.

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.