The approval of Fyarro marks the first for advanced malignant PEComa, a rare cancer that affects only 100-300 people in the US; it's also the first launch for Aadi Biosciences.

The European Medicines Agency had a busy time at its meeting last week. It gave the green light to 11 products, four of which are for rare diseases including ANCA-associated vasculitis, and to a range of treatments for conditions as diverse as non-small cell lung cancer, smallpox, migraine, COPD, COVID-19 and obesity.

The European Medicines Agency is expected to make recommendations on EU marketing authorization for 10 new medicines at its monthly meeting this week. They include products for non-small cell lung cancer, COVID-19, kidney disease, smallpox and migraine.

An increasing number of sophisticated tools are on offer to address new therapeutic challenges and remaining unmet needs.