USA – FDA drug approvals declined last year

Though down from the 2018 peak, the 48 new molecular entities approved by the FDA still amounted to a solid year of innovation

Afterrecord-shattering 2018, new drug approvals came back down to earth in 2019. The US Food and Drug Administration gave the green light to 48 new medicines last year—a slide from the 59 new molecular entities approved in 2018 but higher than the industry’s average productivity over the past decade.

Although technologies like gene and cell therapies are filling the pipeline, trusty small molecules continue to dominate approvals, accounting for 69% of the FDA’s new molecular entities. Fewer antibodies were approved in 2019—just five, or 10%—while modalities like oligonucleotides, RNA interference, and antibody-drug conjugates made frequent appearances on the new drugs list…