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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 EC has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause or caused by adj. endocrine therapy related to breast cancer; regulatory filings are ongoing in other regions
Approval was based on P-III (OASIS) program assessing Lynkuet (120mg, QD, PO), which consists of OASIS-1 (n=396), OASIS-2 (n=400) &…
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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 medicineÂ
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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The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review Â
Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO…

