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Pharmaceuticals

New drug approvals held steady in 2021

The FDA maintained its pace for shepherding new molecular entities to market despite the ongoing pandemic

by Bethany Halford
January 14, 2022 | A version of this story appeared in Volume 100, Issue 2

 

The US Food and Drug Administration approved new drugs at a substantial clip last year, even as the agency continued to maneuver through other urgent business related to the continuing COVID-19 pandemic, including evaluating tests, vaccines for children, and antiviral compounds. The agency approved 50 new molecular entities in 2021, just three fewer than the number it cleared in 2020.

Among the new approvals were 31 small molecules, accounting for 62% of the new drug pipeline. Notable new small-molecule drugs include a long-acting HIV therapy, a novel antifungal, and an inhibitor of KRAS G12C—a cancer target that drugmakers have been pursuing for years.

Larger molecular entities also had a strong year, with several antibodies and protein therapeutics getting the FDA’s nod. The agency also approved two anticancer antibody-drug conjugates, a cholesterol-lowering drug that works through RNA interference, and a controversial antibody treatment for Alzheimer’s disease.


Steady clip
In 2021, the US Food and Drug Administration approved 50 new drugs, a similar number to that of past years despite the ongoing pandemic.
Click here or the image below to view the full interactive table.
Click here to download a PDF of the table.
C&EN lists 2021's new drug approvals.

By the numbers

50

New molecular entities approved in 2021

31

Small-molecule drugs approved

8

Antibody or antibody fragment drugs approved

6

Protein drugs approved

2

Antibody-drug conjugates approved

Source: The US Food and Drug Administration.

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