The DOI matches its Crossref record; 116 of the 116 references it cites were found in a registry or an index.
A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions
Abstract
A total of 378 novel drugs and 27 biosimilars approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2019 were evaluated according to approval numbers by year, therapeutic areas, modalities, route of administration, first-in-class designation, approval times, and expedited review categories. From this review, oncology remains the top therapy area (25%), followed by infection (15%) and central nervous system disorders (11%). Regulatory incentives have been effective as evidenced by an increase in orphan drugs as well as antibacterial drugs approved under the GAIN act. Clinical development times may be increasing, perhaps as a result of the increase in orphan drug indications. Small molecules continue to mostly adhere to "Rule of 5" (Ro5) parameters, but innovation in new modalities is rapidly progressing with approvals for antisense oligonucleotides (ASO), small-interfering RNA (siRNAs), and antibody-directed conjugates (ADCs). Finally, novel targets and scientific breakthroughs that address areas of unmet clinical need are discussed in detail.
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Metadata
- Authors
- Brown, D. G., & Wobst, H. J.
- Venue
- Journal of Medicinal Chemistry
- Publisher
- American Chemical Society (ACS)
- Published
- 2021-02-22
- Volume
- 64
- Issue
- 5
- Pages
- 2312-2338
- ISSN
- 0022-2623 (ISSN-L)
- 1520-4804
- OpenAlex
- W3130309548
- Cited by
- 320
- References
- 116
- FWCI
- 38.57
- Type
- journal article
- Language
- en
- Open access
- closed
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- Brown, D. G., & Wobst, H. J. (2021). A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions. Journal of Medicinal Chemistry. https://doi.org/10.1021/acs.jmedchem.0c01516
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
