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The FDA originally approved Otulfi as a biosimilar in October 2024 based on clinical data that demonstrated the product was highly similar to Stelara.
The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.
AD109 is a once daily pill that consists of aroxybutynin, an antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor.
Brekiya consists of dihydroergotamine mesylate, an ergotamine derivative, in a single-dose autoinjector for subcutaneous administration.
The Teal Wand is an at-home vaginal self-collection device intended to test for 14 types of high-risk HPV that have the highest risk for causing cervical cancer.
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