FDA gives its nod to 53 new drugs in 2020

Despite a pandemic, a steady flow of new molecular entities reached the market last year

The US Food and Drug Administration kept up a blistering pace of new drug approvals last year, all while navigating the urgent evaluation of tests, drugs, and vaccines in development for COVID-19. The agency approved 53 new products in 2020, the second-highest number in more than 20 years.

Of those new molecular entities, 35 were small molecules—which at 66% of the total approvals continue to be a critical component of the drug pipeline. Among the notable approvals: two treatments for Ebola virus, the first fully-approved antiviral for COVID-19, the first oral treatment for spinal muscular atrophy, and the first treatment for children with a rare genetic disease that causes them to develop tumors on their nerves. The year also brought 10 new cancer treatments, including another 2 antibody-drug conjugates, a class that has become an increasingly permanent fixture in the new drug list.

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