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Vertex non-opioid analgesic gets FDA approval
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Vertex’s Journavx, the first analgesic to be approved in a novel class of non-opioid pain medications indicated for moderate to severe acute pain relief.
February 4, 2025
Study findings presented on early stroke-type detection test
By
LabPulse.com staff writers
A new blood test may rapidly distinguish stroke type before people with stroke symptoms reach the emergency department, according to a preliminary study being presented at the American Stroke Association's International Stroke Conference 2025.
February 5, 2025
Beckman Coulter gets FDA breakthrough device designation for Alzheimer's test
By
LabPulse.com staff writers
Beckman Coulter Diagnostics has been granted a U.S. Food and Drug Administration (FDA) breakthrough device designation for its Access p Tau217/β-Amyloid 1-42 assay, designed to identify amyloid pathology indicative of Alzheimer's disease.
January 28, 2025
FDA approves monthly maintenance dosing for Leqembi
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Alzheimer's disease drug Leqembi for a monthly maintenance dose schedule after initial treatment.
January 29, 2025
New Beckman Coulter biomarker immunoassays support Alzheimer's research
By
LabPulse.com staff writers
Beckman Coulter Diagnostics has announced the availability of new research-use-only blood-based biomarker immunoassays designed to advance neurodegenerative disease research.
January 15, 2025
Grifols scores $21M for Parkinson's plasma sample analysis
By
LabPulse.com staff writers
Broader Grifols program seeks disease-revealing clues in more than 100 million plasma samples.
January 14, 2025
Mindray launches AI-enabled cellular analysis line
By
LabPulse.com staff writers
The system is designed to mitigate the risk of low platelet count, according to the company.
January 10, 2025
GeneDx expands exome testing program for pediatric epilepsy patients
By
LabPulse.com staff writers
GeneDx has expanded its patient access program for pediatric epilepsy, which provides access to whole exome sequencing to qualifying pediatric patients.
December 5, 2024
FDA sounds bacteria alarms over CGMP violations in Maine
By
Liz Carey
Tom's troubles highlight the importance of being inspection-ready.
November 21, 2024
Vesalius, GSK announce strategic alliance on neurodegenerative disease treatments
By
LabPulse.com staff writers
Biotech firm Vesalius Therapeutics announced a strategic collaboration with GSK aimed at the discovery and development of therapeutics for Parkinson's disease and another undisclosed neurodegenerative disease.
November 15, 2024
Veravas, Phanes Biotech to collaborate on Alzheimer's tau pathology assay
By
LabPulse.com staff writers
Clinical diagnostics developer Veravas and Phanes Biotech have announced that they will co-develop a blood-based Alzheimer’s disease (AD) tau pathology test.
November 8, 2024
Sunbird Bio shares new data on blood-based Parkinson's diagnostic
By
LabPulse.com staff writers
Biotech firm Sunbird Bio announced new data from a study demonstrating that Sunbird's technology could provide blood-based diagnosis of Parkinson's disease and other neurodegenerative diseases with a high level of accuracy.
November 1, 2024
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