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EMA Marketing Authorization of New Drugs in November 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks  In…

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The US FDA New Drug Approvals in October 2025 

Shots:  Innovation in drug development continues to shape the future of healthcare, driving bold scientific collaborations and transforming the way diseases are treated across every frontier of medicine  In October, the US FDA granted approvals to Boehringer Ingelheim’s Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis and Bayer’s Lynkuet (elinzanetant) for managing moderate to severe…

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