The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
The development comes as stroke remains one of the world’s biggest health threats
Stroke is the second-leading cause of death and the third-leading cause of disability worldwide
The study evaluated asundexian (50 mg), a once-daily oral anticoagulant candidate, versus placebo—both given alongside standard antiplatelet therapy
There are limited treatment options available for patients living with non-diabetic CKD, and the unmet need is high for new treatments to delay kidney disease progression and reduce cardiovascular risk
These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
NAEH can cause heavy or abnormal bleeding and, if left untreated, may progress to uterine cancer
Millions of stroke survivors across the world may soon have a new defense
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
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