The FDA released a statement touting that it has approved 35 drugs YTD which is only 2 less than its best year in the past 10 years (37 in 2009). What's more? The approval times are faster than elsewhere - 24 of the 35 newly approved drugs occurred in the US before any other country in the world and also before the European Union.
According to the agency, of the 35 approvals, two are “breakthroughs” in personalized medicine that were approved with a diagnostic test; seven provide major advances in cancer treatment; 10 are for orphan diseases; 16 were approved under priority review; two-thirds were completed in a single review cycle; three were approved under accelerated approval, and 34 were approved on or before the agreed-upon review time targets, including three cancer drugs approved in less than six months (you can read the complete report here).
Posted by Bruce Lehr Nov 3rd 2011.