The Pharmaceutical Industry in 2018. An Analysis of FDA Drug Approvals from the Perspective of Molecules

Molecules. 2019 Feb 23;24(4):809. doi: 10.3390/molecules24040809.


The Food and Drug Administration approved 59 new drugs (42 New Chemical Entities and 17 Biologics) during 2018. This number breaks the previous record of 53 approved by the same organization in 1996. The 17 new biologics approved in 2018 also represent an important milestone for this kind of drug and they clearly exceed the 12 approved in 2015 and 2017. Herein, the 59 new drugs of the class of 2018 are analyzed from a strictly chemical perspective. The classification has been carried out on the basis of the chemical structure and includes the following: Biologics (antibodies and enzymes); TIDES (peptides and oligonucleotides) and natural products; drug combinations; and small molecules.

Keywords: API; TIDES; antibodies; biologics; chemical entities; drug discovery; fluorine based drugs; natural products; oligonucleotides; peptide; small molecules.

Publication types

  • Review

MeSH terms

  • Antibodies / pharmacology
  • Biological Products / pharmacology
  • Drug Approval / statistics & numerical data*
  • Drug Discovery
  • Drug Industry
  • Humans
  • Molecular Structure
  • Pharmaceutical Preparations / chemistry
  • United States
  • United States Food and Drug Administration


  • Antibodies
  • Biological Products
  • Pharmaceutical Preparations