FDA Issues Complete Response Letter to Janssen Biotech, Inc. for SIMPONI Supplemental Biologics License Application
Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration issued a Complete Response letter for the SIMPONI supplemental Biologics License Application seeking an expanded label in the treatment of active psoriatic arthritis. The application, filed in November 2010, included data from a Phase 3 trial evaluating the effect of SIMPONI in inhibiting the progression of ...

FDA may get two more months to review new drugs
WASHINGTON (Reuters) - U.S. regulators and the drug industry want to extend by two months the deadline for the Food and Drug Administration to approve or reject new drugs.

FDA Announces Changes in Drug Center's Oncology Office
Review divisions to be aligned by expertise, disease-specific areas