Reuters
ImClone, Bristol submit cancer drug to FDA
Thursday August 14, 12:14 pm ET
NEW YORK, Aug 14 (Reuters) - ImClone Systems Inc. (NasdaqNM:IMCL -
News) and Bristol-Myers Squibb Co. (NYSE:BMY - News) said on Thursday
they submitted their experimental cancer drug Erbitux to U.S.
regulators for approval.
The U.S. Food and Drug Administration (News - Websites) in late 2001
refused to review ImClone's original marketing application, citing
poor clinical trial design. The refusal led to an insider trading
scandal that culminated in the imprisonment of former ImClone Chief
Executive Samuel Waksal.