Cancer and rare diseases dominated 2019 drug approvals

In 2019, the US Food and Drug Administration (FDA) approved 48 new drugs. While lower than the agency’s record 59 approvals in 2018, the broad trend for higher numbers continues – the five-year average for 2015–19 is 44. In the decade from 2000–2009, the average was just 25.

Cancer remains the highest individual therapeutic area, with 11 approvals, almost a quarter of the total. Rare diseases – including rare cancers – continue to be well served, with 21 new treatments having orphan drug designation.