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Amgen gets FDA approval for small cell lung cancer therapy
By
LabPulse.com staff writers
Amgen announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved its therapy tarlatamab, to be marketed under the name Imdelltra, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
May 17, 2024
Karius gets FDA breakthrough device designation for infectious disease test
By
LabPulse.com staff writers
Karius announced today that its Karius Test for the diagnosis and management of lung infections in immunocompromised patients has been granted breakthrough device designation from the FDA.
May 16, 2024
Clinical lab to pay $2.5M for rent sham kickback scheme
By
LabPulse.com staff writers
The lab's agreements with physician practices and providers typically provided for the use of an exam room by lab personnel, as well as for the use of basic equipment.
May 17, 2024
BioMarin confirms layoffs and R&D cuts
By
LabPulse.com staff writers
Roctavian, BioMarin's gene therapy for severe hemophilia A, generated $800,000 in net product revenue in the first quarter of 2024.
May 15, 2024
T2 Biosystems to sell $8M in stock in private placement
By
LabPulse.com staff writers
T2 Biosystems has announced that it has signed a definitive agreement to sell approximately $8 million in shares and warrants to a group of investors.
May 16, 2024
FDA issues warning for Cue Health COVID-19 tests
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) issued a warning to consumers and healthcare providers not to use Cue Health's COVID-19 over-the-counter test and its COVID-19 test intended for point-of-care settings due to an increased risk of false results.
May 14, 2024
Northwell Health Cancer Institute opens molecular diagnostics laboratory
By
LabPulse.com staff writers
The Northwell Health Cancer Institute and its Center for Genomic Medicine have opened a new $3.2 million 2,800-sq-ft molecular diagnostics laboratory in Lake Success, NY.
May 13, 2024
Qiagen gets FDA clearance for respiratory syndromic testing panel
By
LabPulse.com staff writers
Qiagen announced that it has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx respiratory syndromic testing panel for clinical use.
May 14, 2024
iHealth gets EUA for combination COVID-19/influenza at-home test
By
LabPulse.com staff writers
Diagnostics developer iHealth Labs has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration for its 3-in-1 COVID-19/Flu A&B Rapid Test Kit for over-the-counter home use.
May 10, 2024
Qiagen partners with FBI on forensics assay
By
LabPulse.com staff writers
Qiagen has announced a collaboration with the FBI to develop a new assay to improve DNA quantification for use in forensics and human identification.
May 8, 2024
Biodesix reports doubling lung nodule testing activity
By
LabPulse.com staff writers
Biodesix has reported that its lung diagnostic test distribution and revenue has increased over 50% compared to this time last year.
May 10, 2024
Myriad Genetics reorganizes EU operations, sells EndoPredict business
By
LabPulse.com staff writers
Precision medicine company Myriad Genetics has signed an agreement to sell its EndoPredict business to French IVD and life sciences firm Eurobio Scientific.
May 9, 2024
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