The fifth annual listing of In Vivo’s Rising Leaders includes entrepreneurs and innovators from across the world who represent the next wave of creativity in health care.

The European Medicines Agency has OKd two new H5N1 jabs, including a pandemic preparedness vaccine intended for use only if a flu pandemic is declared. Eight other products are also heading for EU-wide approval.

10 orphan drugs imported from overseas, and 40 new drug approvals, including many from domestic developers, capped 2023 as one of the busiest years for China's drug regulatory agency, as Beijing pivoted to emphasizing affordable innovation and expanding access to newer therapies for rare conditions.

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.