Dive Brief:
- In 2014, the FDA approved 41 first-of-a-kind drugs—the most since 1996, when 53 such drugs were approved.
- Of the drugs approved in 2014, 15 were for orphan diseases. That's three more than the 12 approved in 2013.
- Another trend that was amplified in 2014? The increasing focus on specialty drugs.
Dive Insight:
Considering the power of lexicon, one of the most important words in the pharmaceutical industry is "innovation."
Last year's 18-year record reflects a high level of innovation on the industry side, and a laudable level of of regulatory efficiency on the part of the FDA. 2015 promises to be just as productive, with some ground-breaking drugs slated for launch.
But one thing that regulators and industry observers are sure to look out for is the post-marketing fate of these drugs. As BioPharma Dive has previously reported, although the FDA has stepped up its game in terms of therapy approvals, the agency has also increasingly relied on post-marketing surveillance and observation.