With an expiration date still more than a year away, here's what the latest details reveal.
The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce that the U.S. Food and Drug Administration (FDA) has accepted for priority ...
FDA fast tracks ADHD drug centanafadine, targeting approval by July 24 for treatment across all age groups, based on phase 3 trial results.
termed "ascending dose," was specifically designed to avoid acute tolerance, which is believed to be the cause of the diminished effectiveness of intermediate-acting methylphenidate preparations ...