OBJECTIVES: We sought to describe the new molecular entities (NMEs) and new therapeutic biologic applications (BLAs) approved by the US Food and Drug Administration (FDA) in the period 1980-2012, and to assess differences in drug approvals and discontinuations between oncology products and products from other therapeutic classes.  METHODS: Drug approval data were collected from FDA databases publicly available on its website, and the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (1980-2013).  The unit of analysis was the pharmaceutical active ingredient or combination of ingredients approved by the FDA. Data were updated to December 31, 2012. Descriptive analysis and the chi-square test were used in the analysis. RESULTS: The FDA listed 2,479 approved active ingredients or combinations of active ingredients in the period 1980-2012; including 99 BLAs and 2,380 NMEs. Oncology products represented 5.3% (n=126) of NMEs and 43.4% (n=43) of BLAs. The FDA listed 34 oncology products approved before 1980, 12 in the 1980s, 49 in the 1990s, 51 in the 2000s, and 23 in 2010-2012.  The oncology products (0.6%) and other products (23.8%) were approved as a fixed-dose combination (p<0.001). In January 1, 1980 the FDA listed 949 products of which 33 (3.5%) were oncology products. In the period 1980-2012, the FDA approved 1,530 products, including 136 oncology products (8.9%). In December 31, 2013, 92.9% of all the approved oncology products and 68.7% of other products were listed as marketed by the FDA (p<0.001). CONCLUSIONS: Oncology drugs experienced a rapid increase in approvals in the past 2 decades while the approvals in other therapeutic classes declined significantly. Biologics represented a larger proportion of the approvals of oncology products than products from other therapeutic classes. Pharmaceutical companies continue to invest in R&D in oncology and other niche markets without adequate therapeutic alternatives.