"Lilly and Incyte to seek approval of alopecia JAK inhibitor in children" was originally created and published by ...
While the trial met its primary endpoint, the FDA stated in its letter that the application could not be approved in its current form.
The FDA has accepted Pharming Group’s supplemental new drug application for leniolisib in treating activated phosphoinositide ...
Kids with a rare bone cancer called Ewing sarcoma might live longer if prescribed pazopanib, a drug that blocks blood supply ...
The FDA issued a complete response letter for SYD-101, citing insufficient evidence of effectiveness despite achieving ...
Ewing sarcoma is one of the most common bone cancers seen in children, and if it spreads, it can be deadly. One study found that under a quarter of children with multi-metastatic Ewing sarcoma ...
Yuflyma (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent ...
The FDA approved expanded indications of Yuflyma and its unbranded version to treat hidradenitis suppurativa in adolescents aged 12 years and older and uveitis in children aged 2 years and older, ...
The FDA has accepted for review the sBLA for Afrezza (insulin human) inhalation powder in children and adolescents with type 1 or 2 diabetes.