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Amgen gets FDA approval for small cell lung cancer therapy
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).
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Amgen gets FDA approval for small cell lung cancer therapy
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Karius gets FDA breakthrough device designation for infectious disease test
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Clinical lab to pay $2.5M for rent sham kickback scheme
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BioMarin confirms layoffs and R&D cuts
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iHealth gets EUA for combination COVID-19/influenza at-home test
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Karius gets FDA breakthrough device designation for infectious disease test
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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.
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Clinical lab to pay $2.5M for rent sham kickback scheme
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Roctavian, BioMarin's gene therapy for severe hemophilia A, generated $800,000 in net product revenue in the first quarter of 2024.
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Qiagen gets FDA clearance for respiratory syndromic testing panel
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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.
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iHealth gets EUA for combination COVID-19/influenza at-home test
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May 10, 2024
Qiagen partners with FBI on forensics assay
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Biodesix reports doubling lung nodule testing activity
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Biodesix has reported that its lung diagnostic test distribution and revenue has increased over 50% compared to this time last year.
May 10, 2024
University of Florida researchers develop CRISPR-based assay for HPV detection
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Researchers at the University of Florida have developed a testing method that utilizes CRISPR gene-editing technology to detect HPV in blood or saliva samples that could promote earlier cervical cancer detection.
May 7, 2024
Myriad Genetics reorganizes EU operations, sells EndoPredict business
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Precision medicine company Myriad Genetics has signed an agreement to sell its EndoPredict business to French IVD and life sciences firm Eurobio Scientific.
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Geneoscopy receives FDA approval for CRC screening test
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May 7, 2024
German court rules patent invalid in 10x infringement suit against NanoString
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The German Federal Patent Court has ruled invalid the German part of a patent at the heart of a lawsuit brought by 10x Genomics against NanoString Technologies, now a Bruker subsidiary.
May 8, 2024
Karius raises $100M in series C funding
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Diagnostics firm Karius has secured $100 million in series C funding in a recent financing round.
May 6, 2024