In 2023, the U.S. Food and Drug Administration (FDA) approved 55 new drugs, marking a significant year in pharmaceutical advancements. Monoclonal antibodies (mAbs) led with 12 approvals, underscoring their pivotal role in modern drug therapies. Notably absent were antibody-drug conjugates (ADCs), which did not see new entries this year.
A highlight of 2023 was the approval of nine drugs categorized as TIDES (peptides and oligonucleotides), including five peptides and four oligonucleotides, reflecting ongoing innovation in biologically derived therapies.
Natural products emerged as a major source of inspiration, contributing 10 new drugs to the market. These products continue to provide unique chemical structures and therapeutic potential that enrich the pharmaceutical pipeline.
The year also witnessed the approval of pegylated drugs, signaling a renewed interest in extending drug half-lives through pegylation. Two bispecific drugs further showcased advancements in targeted therapeutic approaches.
Chemically, fluorine and/or N-aromatic heterocycles featured prominently in the molecular compositions of approved drugs, highlighting their importance in modern drug design strategies.
This comprehensive analysis categorizes the 55 FDA-approved drugs of 2023 based on their chemical structures, offering insights into the diverse trends shaping contemporary drug development.
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