In 2023, seventy novel drugs received market authorization for the first time in either
Europe (by the EMA and the MHRA) or in the United States (by the FDA). Confirming
a steady recent trend, more than half of these drugs target rare diseases or intractable
forms of cancer. Thirty drugs are categorized as “first‐in‐class” (FIC), illustrating
the quality of research and innovation that drives new chemical entity discovery and
development. We succinctly describe the mechanism of action of most of these FIC drugs
and discuss the therapeutic areas covered, as well as the chemical category to which
these drugs belong. The 2023 novel drug list also demonstrates an unabated emphasis
on polypeptides (recombinant proteins and antibodies), Advanced Therapy Medicinal
Products (gene and cell therapies) and RNA therapeutics, including the first‐ever
approval of a CRISPR‐Cas9‐based gene‐editing cell therapy.
