Urovant Sciences announces US FDA acceptance of NDA for Vibegron to treat overactive bladder
The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not
The US Food and Drug Administration (FDA) has accepted for priority review Otsuka Pharmaceutical’s new drug application (NDA) submitted for centanafadine, an investigational, once-daily extended-release capsule for attention-deficit hyperactivity disorder (ADHD) treatment.
Specifically, they identified novel dual inhibitors of plasmepsins IX and X (PMIX and PMX), two proteases that are essential to Plasmodium falciparum, the predominant cause of the most
AL101, Ayala’s lead product candidate, is a potent, selective, injectable small molecule gamma secretase inhibitor (GSI) and was granted Orphan Drug Designation in May 2019 for the treatment