As biologic drug patents begin to expire, generic versions will hit the market—but how will they be regulated?

Delivering a missing enzyme to the brains of paralyzed children with a rare, life-threatening neurological disease restores movement and builds muscle mass.

The US Food and Drug Administration has relaxed some of the rules governing how companies must test the sterility of materials used to make biologic drugs.

Large molecules are more likely to make it to market these days than small molecules, according to new reports.

The government says regulatory requirements for generic biological therapies will have to be tailored to the treatment in question.