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
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors
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