27 Hot Drugs Facing FDA Approval in 2012
BOSTON (TheStreet) -- Here's an updated look at the biotech and pharmaceutical companies with pending FDA drug approval decisions in 2012. The calendar on the following pages (updated from when it was last published on Nov. 29) captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between January and July 2012. As every savvy biotech investor ...

Janssen Research & Development Submits Application to U.S. FDA for XARELTO (rivaroxaban) to Reduce Secondary ...
RARITAN, N.J. , Dec. 29, 2011 /PRNewswire/ -- Janssen Research & Development, LLC (JRD) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ...

Fabricant on NDI draft guidance: Thanks for your 146,000 pages of comments. We ll get back to you
Those hoping the Food and Drug Administration (FDA) is preparing for a major climb down on its draft guidance on new dietary ingredients (NDIs) will draw little comfort from comments made by the agency's supplements chief yesterday.