Compliance Management / Large Molecule / Small Molecule

Pharma, Biotech Drug Approvals Reach an 18-year High

Jan 02, 2015


U.S. drug approvals in 2014 hit their highest level since 1996, driven by expensive new treatments for cancer and rare diseases, according to a Reuters article.

The FDA's Center for Drug Evaluation and Research approved 41 novel medicines in 2014 -- 14 more than last year. That total is second only to the record-holding 53 approvals in 1996.

In addition, the European Medicines Agency, which includes generic drugs in its list, recommended 82 new medicines last year, an increase from 79 in 2013 and 57 in 2012.

Nearly 40 percent of new drugs approved in the United States last year were for rare diseases, the article said. Among 2014's highlights were two cancer drugs that help the body's own immune cells fight tumors and promise longer-lasting treatment with fewer adverse side effects. Read the full story