Policy and Regulation: Page 2

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
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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
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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
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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
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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
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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
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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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New bills sound alarms on foreign adversaries and medical diagnostics
By LabPulse.com staff writers
Legislators wary of certain foreign biotech companies have introduced bipartisan, bicameral legislation that would ban federal contracts and funding mechanisms to companies with ties to foreign adversaries.
January 26, 2024
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Precision medicine at tipping point with looming FDA LDT oversight
By Liz Carey
FDA targets companion diagnostics (CDx) LDTs first. In addition, CAP and AdvaMedDx set clear expectations, and what to know about the FDA-CMS joint statement on FDA oversight.
January 25, 2024
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Sensorion receives clinical trial approval for congenital deafness gene therapy
By LabPulse.com staff writers
French biotech firm Sensorion has received approval to initiate a phase I and II clinical trial in France of SENS-501 (the OTOF-GT program), its gene therapy for gene-mediated hearing impairment.
January 22, 2024
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Imvaria gets FDA marketing authorization for Fibresolve
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Imvaria for the use of Fibresolve.
January 16, 2024
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NowDiagnostics submits FDA de novo request for OTC syphilis test
By LabPulse.com staff writers
NowDiagnostics has submitted a de novo authorization request to the U.S. Food and Drug Administration (FDA) for its First to Know over-the-counter (OTC) syphilis test.
January 10, 2024
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