The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.

The FDA has accepted Otsuka’s New Drug Application for centanafadine, a first-in-class norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit ...

With an expiration date still more than a year away, here's what the latest details reveal.

The MarketWatch News Department was not involved in the creation of this content.-- Centanafadine is an investigational compound for the treatment of ADHD in children, adolescents ...

Otsuka Pharmaceutical announced that the FDA is reviewing investigational centanafadine -- a potential first-in-class ...

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor designed to address the core symptoms of ADHD in children and adults.

The agency is currently reviewing the study findings ...

The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, ...

The FDA has started a priority review of Otsuka Pharma's triple-acting drug for attention-deficit hyperactivity disorder ...

Understood reports that artificial food dyes, like Red 40, may worsen ADHD symptoms in some children, prompting a phase-out ...

Kenvue, the American company that makes Tylenol, says the U.S. Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible ...