Market Overview

GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent in US and Europe

GE Healthcare today announced that regulatory bodies in the United
States and Europe have accepted its applications for review of the
investigational PET amyloid imaging agent [18F]flutemetamol,
a positron emission tomography (PET) imaging agent. A New Drug
Application (NDA) was submitted to the U.S. Food and Drug Administration
(FDA) for [18F]flutemetamol use in the visual detection of
beta amyloid in the brains of adult patients with cognitive impairment
who are being evaluated for Alzheimer's disease (AD) or other cognitive
disorders. Additionally, a Marketing Authorisation Application (MAA) was
submitted to the European Medicines Agency for [18F]flutemetamol
use in the visual detection of beta amyloid in the brains of adult
patients who are being evaluated for AD.

See full press release

Posted-In: News Guidance Management M&A Global

 

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