Bristol-Myers Squibb is going to have to wait a while longer before it knows whether the FDA will allow it to market belatacept to help prevent patients' immune systems from rejecting new kidney transplants. Regulators said that they want to look over 36-month follow-up data from the Phase III study. The company had submitted 24-month data with its biologics application.
Regulators also want more info on "the manufacturing of belatacept and the proposed risk evaluation...