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GC Biopharma Announces US FDA Approval for ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI) - Vimarsana News

GC Biopharma Announces US FDA Approval for ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)

/PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved ALYGLO (immune globulin intravenous,...

Bayer cancels asundexian phase III study program - Vimarsana News

Bayer cancels asundexian phase III study program

The decision to stop the study is based on the recommendation by the Independent Data Monitoring Committee (IDMC). IDMC monitoring showed an inferior efficacy of asundexian compared to the control arm of the study. "A phase III study investigating asundexian compared to Apixaban in patients with atrial fibrillation at risk for stroke is being stopped early," the company said in a statement.

Source: yahoo.com
Bayer cancels asundexian phase III study programme - Vimarsana News

Bayer cancels asundexian phase III study programme

Germany's Bayer AG said on Sunday it is cancelling a phase III study program to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor. Read more at straitstimes.com.

New asundexian Phase III study to include patients with atrial fibrillation ineligible for oral anticoagulant treatment - Vimarsana News

New asundexian Phase III study to include patients with atrial fibrillation ineligible for oral anticoagulant treatment

WHIPPANY, N.J.--(BUSINESS WIRE)--Nov 10, 2023--

New asundexian Phase III study to include patients with atrial fibrillation ineligible for oral anti - Vimarsana News

New asundexian Phase III study to include patients with atrial fibrillation ineligible for oral anti

New study includes patients aged ≥65 years with atrial fibrillation (AF) at high risk for ischemic stroke or systemic embolism who are deemed ineligible for oral anticoagulant (OAC) treatment due to increased risk of bleedingOCEANIC-AFINA, the latest Phase III study in the OCEANIC clinical trial program, will invest...