Jacobus Pharmaceutical Co. Inc

Rare and pediatric disease drug sponsors and the US Food and Drug Administration could resolve several ongoing rare and pediatric drug development issues in a compromise bill to fund the government th

The US Food and Drug Administration is routinely sued by companies who object to its decisions, but Commissioner Robert Califf is concerned that judges are now more willing to overrule FDA’s scientifi

Vanda Pharmaceuticals, Inc. has continuously clashed with the US Food and Drug Administration and turned to the courts to try to compel the agency to take action in its favor in long-simmering battle

Among the US Food and Drug Administration’s enormous workload, one task is consuming much more of its time: determining if products qualify for three-year exclusivity when the sponsor conducts a new c