Xia Fxia News Today

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

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.

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.

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

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...

The FDA has granted Fast Track designation to milvexian across 3 indications including ischemic stroke, ACS, and atrial fibrillation.

The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients,... | May 25, 2023

The FDA has granted Fast Track designation to milvexian across 3 indications including ischemic stroke, ACS, and atrial fibrillation.

16 May 2023 | 08:29 AM Europe/Amsterdam ... | May 16, 2023

The FDA has granted Fast Track designation to asundexian to prevent stroke and systemic embolism in patients with atrial fibrillation.