FDA drug approval rate for 2011 likely to exceed 2010 rate (Morning Read)
If you feel like you've been reading a lot about FDA drug approvals this year, it's because you have. In a testimony before the House Energy and Commerce's health committee last week, the head of the FDA's drug division reported that the FDA approved 20 new drugs already this year, compared to 21 in all of 2010, and is on par to exceed approval numbers for the past several years.

The Truth About 2011's New Drug Approvals
As many new drugs were approved in the first half of this year as in all of last. That's good news, right? Maybe not.The Food and Drug Administration has approved 20 new medicines in the first half of this year, one short of of the total for all of 2010. Janet Woodcock, head of the FDA division that handles new drug approvals, said in Congressional testimony that this shows the FDA is not ...

FDA Issues Complete Response Letter to Janssen Biotech, Inc. for SIMPONI Supplemental Biologic License Application
Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration issued a Complete Response letter for its supplemental Biologics License Application for SIMPONI . The application, filed in September 2010, seeks to expand the SIMPONI physician label to include inhibiting the progression of structural damage, inducing major clinical response and maintenance of reduction of ...