The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies ...

Jardiance 10 mg tablets are now approved to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD based on data from the EMPA-KIDNEY phase III study.

This program aims to provide a mechanism for the FDA and EMA to jointly consider, and exchange views with applicants, on scientific questions during the development phase of hybrid/complex generic ...