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Policy and Regulation: Page 2
Highlights of March 2024 LDT hearing with lawmakers
By
Liz Carey
The VALID Act appeared to win hearts over the hammer of a forthcoming FDA final rule expected to drop heavy regulations on clinical laboratory developed tests (LDTs), a hearing of the House Subcommittee on Health revealed Thursday.
March 22, 2024
WHO launches new guidance on TB diagnostics
By
LabPulse.com staff writers
The World Health Organization has published updated guidance for the diagnosis of tuberculosis (TB), including new recommendations on the use of next-generation sequencing for the diagnosis of drug-resistant TB.
March 21, 2024
FDA updates draft guidance for Alzheimer's drug development biomarkers
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has released an updated draft guidance for the use of biomarkers aimed at sponsors and pharmaceutical companies developing drugs intended to treat early Alzheimer's disease.
March 14, 2024
Bluebird Bio signs state Medicaid agreement for SCD gene therapy
By
LabPulse.com staff writers
Bluebird Bio has signed its first outcomes-based Medicaid agreement for its sickle-cell disease (SCD) gene therapy Lyfgenia with the state of Michigan.
March 11, 2024
Boston Scientific gets FDA approval for drug-coated balloon catheter
By
LabPulse.com staff writers
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Agent drug-coated balloon, a paclitaxel-coated balloon catheter sized to fit within blocked or constricted coronary arteries to treat coronary in-stent restenosis.
March 4, 2024
German regulatory agency opens review of Thermo Fisher, Olink deal
By
LabPulse.com staff writers
Germany’s antitrust regulatory agency, the Bundeskartellamt, has moved into a phase II review of Thermo Fisher’s acquisition of Swedish proteomics firm Olink.
February 22, 2024
FDA grants accelerated approval to Iovance’s melanoma cell therapy
By
LabPulse.com staff writers
The FDA granted accelerated approval to Iovance Biotherapeutics’ T-cell therapy treatment for unresectable or metastatic melanoma.
February 21, 2024
CorDx submits EUA application for COVID-19/influenza rapid test
By
LabPulse.com staff writers
CorDx has submitted an Emergency Use Authorization (EUA) application for its CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test to the U.S. Food and Drug Administration (FDA).
February 10, 2024
T2 Biosystems gets FDA nod to expand bacteria panel
By
LabPulse.com staff writers
T2 Biosystems announced it received 510(k) clearance to add A. baumannii to its T2Bacteria Panel.
February 12, 2024
Why many high-risk IVDs are being reclassified
By
LabPulse.com staff writers
The FDA announced that its Center for Devices and Radiological Health (CDRH) will reclassify most in vitro diagnostics (IVDs) that are in the high-risk category to moderate risk to allow their manufacturers an easier path to FDA clearance.
February 1, 2024
FDA orders new info warnings on CAR-T therapies
By
LabPulse.com staff writers
Following its review of reports of T-cell malignancies associated with the administration of six CAR-T immunotherapies, the FDA has instructed the manufacturers to include warnings in the prescribing info for the therapeutics.
January 30, 2024
FDA accepts 1st AI-based tool into Istand pilot program
By
LabPulse.com staff writers
A mental health assessment tool has become the first AI-powered tool to be accepted into the U.S. Food and Drug Administration's (FDA) Innovative Science and Technology Approaches for New Drugs (Istand) pilot program for advancing drug development.
January 26, 2024
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