FDA Wants More Data From Celgene

Regulators are requesting more information from Celgene (CELG Quote) to support the biotech company's bid to get its leprosy treatment Thalomid approved for fighting blood cancer.

The Food and Drug Administration conditionally approved Celgene's application but said it wants to see updated safety information, additional patient data and revised product labeling before it makes a final decision.

Though Thalomid is FDA-approved specifically for treating leprosy, the majority of prescriptions for the drug are written for multiple myeloma, a progressive blood disease. The condition is a cancer of the plasma cell, a key part of the immune system that makes antibodies to help fight infection and disease. ...