FDA to Unveil Covid Shot Policy
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Nearly 4,500 cases were pulled from shelves in 23 states after it was found that the affected cans had been mislabeled.
By Stephanie Brown HealthDay ReporterMONDAY, May 19, 2025 (HealthDay News) -- Last week, the U.S. Food and Drug Administration announced a move to improve transparency and strengthen the safety of chemicals used in the nation's food supply.
The FDA has granted 510(k) marketing clearance to the first in vitro blood-based biomarker diagnostic device for Alzheimer’s disease. Fujirebio’s Lumipulse G pTau217/ -Amyloid 1-42 Plasma Ratio was developed for the early detection of amyloid plaques associated with AD in adults aged 55 years and older who show signs of the condition,
The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, making the test the first to get signoff to aid in the early detection of the disease in the United States.
Nationwide recall affects five types of dry eye treatments due to manufacturing violations and sterility concerns.
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The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.
Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of cognitive decline.
US Food and Drug Administration Commissioner Marty Makary named agency veterans to lead tobacco regulation and inspections, two high-profile areas, according to documents seen by Bloomberg.