Articles related to FDA

The Sonu Band, now FDA-cleared for children 12+, showed a -2.74 mean TNSS improvement with no adverse events in a 2-week study.

Neffy 1mg expands access to emergency epinephrine for children under 30 kg, with a user-friendly nasal spray format and broad affordability programs.

Regulatory action targets concentrated ingestible fluoride products despite lack of formal approval process, citing microbiome and systemic health concerns in pediatric populations.

FDA officials emphasize that unlike other high-income nations targeting elderly and high-risk populations, the US previously maintained universal vaccination recommendations for all Americans over 6 months, a policy they now consider insufficiently evidence-based.

Blood biomarker testing offers 91.7% accuracy in detecting amyloid plaques while providing more accessible alternative to cerebrospinal fluid analysis, though confirmation via PET or CSF remains necessary for indeterminate results.

Company leadership demands FDA explanation for approving identical treatment in patients with CIS while refusing filing for those without CIS, despite same trial data showing comparable clinical benefits and safety profiles.