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Related Experiment Video

Updated: Nov 7, 2025

Quantitative Structure-Activity Relationship, Activity Prediction, and Molecular Dynamics of Non-nucleotide Reverse Transcriptase Inhibitors

Quantitative Structure-Activity Relationship, Activity Prediction, and Molecular Dynamics of Non-nucleotide Reverse Transcriptase Inhibitors

Published on: May 9, 2025

New Drugs Approved in 2020.

Alex M Ebied¹, Hesham Elmariah², Rhonda M Cooper-DeHoff³

¹Department of Clinical Sciences, High Point University Fred Wilson School of Pharmacy, NC.

The American Journal of Medicine

|May 3, 2021

Summary

In 2020, the US Food and Drug Administration approved 53 new drugs, with most receiving expedited review and many targeting rare diseases. This highlights accelerated pathways for novel therapeutics in the US.

Keywords:

Accelerated approval Fast track Novel drugs Priority review US Food and Drug Administration

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Area of Science:

Pharmacology and Therapeutics
Drug Regulatory Affairs

Background:

The US Food and Drug Administration (FDA) plays a critical role in evaluating and approving new medications.
Understanding trends in drug approvals provides insights into therapeutic advancements and regulatory efficiency.

Purpose of the Study:

To summarize the novel drugs approved by the US Food and Drug Administration in 2020.
To analyze the utilization of expedited review pathways and the prevalence of rare disease treatments among novel drug approvals.

Main Methods:

Review of publicly available data on novel drug approvals by the US Food and Drug Administration for the year 2020.
Categorization of approved drugs based on review pathway and therapeutic indication (rare disease treatment).

Main Results:

A total of 53 novel drugs were approved by the US Food and Drug Administration in 2020.
Of these, 36 (68%) were approved via an expedited review pathway.
Furthermore, 31 (58%) of the approved novel drugs were indicated for the treatment of rare diseases.

Conclusions:

The US Food and Drug Administration demonstrated a significant reliance on expedited review pathways for novel drug approvals in 2020.
A substantial proportion of novel drugs approved in 2020 were intended for rare disease treatment, indicating a focus on unmet medical needs.