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Ischemic Attack Articles & Analysis

4 news found

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022. Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. ...

ByBayer AG


Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke events in patients with atrial fibrillation as well as patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack involving up to 30,000 patients Bayer drives the development of its ...

ByBayer AG


Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation

Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation

The primary efficacy endpoint was a composite of MALE and MACE, ie. acute limb ischemia, major amputation of a vascular etiology, heart attack (myocardial infarction, MI), ischemic stroke or cardiovascular death. ...

ByBayer AG


BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

“The published results from our clinical trials to date [3], [4]. [5],[6], [7] have met our high expectations in showing the therapy’s ability to address the loss of heart function in ischemic heart failure. We look forward to completing our Phase III trial and engaging with the FDA as we move closer to the prospect of benefiting patients whose lives are severely ...

ByBiocardia, Inc.

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