Daily Dose - Mar 10th, 2026
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March 10, 2026
FDA regulatory actions regarding Novo Nordisk site result in CRL for Incyte
The agency issued a Complete Response Letter for Incyte’s supplemental Biologics License Application, citing inspection findings at Novo Nordisk’s fill-finish facility.
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CSL breaks ground on $1.5B expansion at Illinois biologics plant
The project will expand plasma-derived therapy production capacity and add at least 300 jobs at the company’s Kankakee manufacturing site.
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Lonza, Genetix Biotherapeutics expand gene therapy manufacturing deal
The extended agreement will increase manufacturing capacity in Houston to support demand for the approved Zynteglo beta-thalassemia gene therapy.
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