Rapid-acting ADHD treatment Azstarys now approved in China
ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood
ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The study will run across 18 sites and enroll roughly 200 patients over 24 months
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
At one year, the drug met its primary and all key secondary endpoints, delivering significantly better weight maintenance than placebo
The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway
The trial tested six injectable doses and three oral doses over as long as 36 weeks
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