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When starting school, younger children are more likely to be diagnosed with ADHD, study says

Could a child’s birthday put him or her at risk for an ADHD misdiagnosis? The answer appears to be yes, at least among children born in August who start school in states where enrollment is cut off at a Sept. 1 birth date, according to a new study led by Harvard Medical School researchers. The… Read More »

HIV self-test app connects users to care, FDA proposes De Novo update, and more digital health news briefs

De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges… Read More »

With Gamifant launch rolling, Sobi unveils more data backing the rare disease med

SAN DIEGO—Armed with last month’s FDA approval, Sobi is rolling out its newly minted rare disease drug Gamifant with a small, targeted sales force, and Monday it unveiled more of the data that won the agency’s favor in the first place. In a phase 2/3 trial of Gamifant in primary haemophagocytic lymphohistiocytosis (HLH), 64.7% of… Read More »