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By the Numbers: New Biologic License Application Filings and Drug Approvals, 2007-2016
Cancer Discovery
|February 8, 2017
Abstract:
The FDA approved 22 novel drugs in 2016, down from 45 in 2015. Four of the new therapies are for cancer treatment, and two are for cancer diagnosis.
Insights
The U.S. Food and Drug Administration (FDA) approved 22 new drugs in 2016, a decrease from 2015. Four of these novel therapies were designated for cancer treatment and two for cancer diagnosis.
Area of Science:
- Pharmaceuticals and Regulatory Science
- Oncology
- Drug Development
Background:
- The U.S. Food and Drug Administration (FDA) plays a critical role in evaluating and approving new medical treatments.
- Tracking the number of novel drug approvals provides insight into the pace of pharmaceutical innovation.
Purpose of the Study:
- To report the number of novel drugs approved by the FDA in 2016.
- To specifically detail the approvals related to cancer therapies and diagnostics.
Main Methods:
- Data compilation of FDA-approved novel drugs for the year 2016.
- Categorization of approved drugs based on therapeutic area, with a focus on oncology.
Main Results:
- A total of 22 novel drugs received FDA approval in 2016.
- This represents a significant decrease compared to the 45 novel drugs approved in 2015.
- Four of the 2016 approvals were for cancer treatments, and two were for cancer diagnostics.
Conclusions:
- The number of novel drug approvals by the FDA declined in 2016 compared to the previous year.
- Oncology remains a key area for new drug development and diagnostic tools, with multiple approvals in 2016.
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