News

Seeking Alpha14d
Novavax jumps as FDA clears COVID-19 vaccine
The FDA cleared the biologics license application for Nuvaxovid for immunization against COVID-19 in adults 65 years and older, and individuals 12 through 64 years with at least one underlying ...
Insider Monkey15d
FDA Clears Novavax, Inc. (NVAX)’s COVID-19 Vaccine with Usage Restrictions
The outlook for the vaccine became uncertain after the FDA failed to meet its April 1 approval deadline. Adding to the uncertainty, U.S. Health and Human Services Secretary Robert F. Kennedy Jr ...
The American Journal of Managed Care15d
FDA Clears First Blood Test for Early Detection of Alzheimer-Linked Amyloid Plaques
The FDA cleared marketing for the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer disease. The FDA has cleared the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio ...
Orange County Business Journal15d
FDA Clears Makani Science’s Bandage-Sized Respiratory Monitor
The process was delayed due to the FDA changing its standards, forcing the company to repeat its clinical trials and meet new cybersecurity requirements. “We performed, we executed and got the ...
AARP15d
What to Know About the First FDA-Cleared Blood Test for Alzheimer’s Disease
Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) has green-lit a blood test that can help doctors diagnose Alzheimer’s disease, the most common form of dementia. It is ...
BioPharma Dive15d
FDA OKs first blood test to aid Alzheimer’s diagnosis
Fujirebio, a Japanese diagnostics company, has given physicians a new testing option by securing 510(k) clearance for its Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. The FDA cleared the test for ...
Medical Device Network15d
FDA grants 510(k) clearance to Fujirebio’s blood-based test for Alzheimer’s
Credit: chayanuphol / Shutterstock. The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) ...
medtechdive15d
FDA clears first blood test to aid Alzheimer’s diagnosis
The FDA cleared the test for the early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease. The presence of amyloid ...
MedCity News15d
Alzheimer’s Disease Now Has Its First FDA-Cleared Blood Test
Patients now have an alternative. The FDA has cleared a new Fujirebio Diagnostics test that detects signs of the disease from a sample of patient blood, marking what the agency says is the first ...
Sierra Sun Times15d
FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease - Says New Test Provides Less Invasive Option, Reduces Reliance on PET Scans and Increases Diagnosis ...
Similar FDA-authorized/cleared tests, one from the same company as this new test, are used with cerebrospinal fluid (CSF) samples, which are collected through an invasive lumbar puncture ...
Hosted on MSN16d
FDA clears 1st blood test to help diagnose Alzheimer's disease
The test measures two proteins that are linked to amyloid plaques in the brain, which are among the hallmarks of Alzheimer's. Newsom plays hardball with Bass over LA funding amid California budget ...