Bristol abatacept BLA rolling along
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Remaining sections of Bristol-Myers Squibb's rolling BLA for abatacept will be submitted in early 2005, the firm says. The rheumatoid arthritis biologic is part of FDA's Continuous Marketing Application Pilot 1 program, which provides for submission in "reviewable units." Complete nonclinical and clinical sections have already been filed, Bristol says...