Considerations for Moderna's move to get an EUA for the COVID-19 vaccine in young kids

Once-daily icotrokinra versus placebo demonstrated clinically significant skin clearance in those with moderate-to-severe plaque psoriasis.

Results demonstrated that daily oral infigratinib treatment led to increases in annualized height velocity and improvement in body proportionality.

With this expanded FDA clearance, the wearable becomes the first FDA-cleared, non-drug therapy to treat acute migraines in children.

The application indication is for adults and pediatric patients aged 12 years and older with CSU whose disease is not adequately controlled with H1 antihistamines.

With the decision, Kebilidi becomes the first FDA-approved gene therapy for AADC deficiency, and is indicated for adult and pediatric patients.

A target action date for potential approval of prademagene zamikeracel (pz-cel) has been set for April 29, 2025.