Braeburn Inc.

“We’ve seen some tremendous acceleration in science over the past few years and that science is the driving force behind new medicines. The fundamental need for these new medicines is the underpinning

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

Infectious disease provided the backdrop for both of the US FDA’s novel approvals last week, one an antiviral and one an antibiotic. The antiviral is already familiar to patients and prescribers. Pfi

Two first-in-class novel biologics cleared the US Food and Drug Administration on 17 December, bringing the annual approval count for the FDA’s Center for Drug Evaluation and Research to 48 with just