The company announced data from the Phase III SPRING study of Takhzyro in children aged 2-11; there is no approved long-term prophylactic therapy for children under 6.

From intranasal corticosteroids to a lice treatment, and from an addition to the OTC PPI market to the first nonprescription acne drug reaching the market through an NDA, US OTC switches in the past 10 years, since FDA began considering widening switch opportunities, haven’t lacked for variety.

Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.

SK Bioscience has received the world’s first approval of its in-house developed recombinant protein COVID-19 vaccine SKYCovione (GBP510), in its home market of South Korea, two years after it began development. Strong support from the domestic government and international cooperation helped pave the way.