Roche, Eli Lilly Alzheimer's Blood Test to Get Expedited FDA Review
By Adria Calatayud
Roche Holding said a blood test for earlier diagnosis of Alzheimer's disease it is developing together with Eli Lilly will get an expedited review by the U.S. Food and Drug Administration.
The Swiss pharmaceutical giant said Thursday that the Elecsys pTau217 test received the so-called breakthrough device designation from the FDA, a program designed to accelerate development and review of medical devices.
Roche said the test relies on a biomarker that has shown the ability to distinguish Alzheimer's disease from other neurodegenerative disorders and strong performance relative to other biomarkers in research settings.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
April 11, 2024 01:33 ET (05:33 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
5 Undervalued Stocks to Buy to Play a Little Defense
-
Markets Brief: AI Leaders Excel In Earnings Season So Far
-
What History Tells Us About the Fed’s Next Move
-
What’s Happening In the Markets This Week
-
Alphabet’s New Dividend: What Investors Need to Know
-
Going Into Earnings, Is Palantir Stock a Buy, a Sell, or Fairly Valued?
-
Going Into Earnings, Is Eli Lilly Stock a Buy, a Sell, or Fairly Valued?
-
What’s the Difference Between the CPI and PCE Indexes?
-
After Earnings, Is Tesla Stock a Buy, a Sell, or Fairly Valued?
-
After Earnings, Is GE Aerospace Stock a Buy, a Sell, or Fairly Valued?
-
3 Good Stocks to Buy with Your Tax Refund in 2024 (Or with Any Extra Money)
-
SoFi Earnings: Revenue Growth Slows on Lower Loan Growth and Higher Credit Costs
-
Tesla: Full Self-Driving Approval In China Supports Our View for Deliveries Growth In 2024
-
Philips Earnings: Firm Reaches $1.1 Billion Settlement Agreement
-
AbbVie Earnings: Next-Generation Immunology Drugs Help Offset Humira Biosimilar Pressure
-
Exxon Earnings: Ignore Earnings Shortfall as Long-Term Growth and Improvement on Track