Roche announced on Monday that its Ventana PD-L1 (SP263) assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in lung cancer patients.
Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.
The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.
Biocartis said Thursday that it has secured US Food and Drug Administration 510(k) clearance for a microsatellite instability (MSI) assay to screen for Lynch syndrome in colorectal cancer patients.
The $3.95 billion worldwide molecular diagnostic POC testing market is seeing increasing international activity with China becoming a particularly intriguing part of the Asia Pacific region according to The Market and Future Potential for Molecular Point of Care, published by Kalorama Information.
The US Food and Drug Administration said on Friday evening that it has issued an Emergency Use Authorization for Lucira Health's Lucira COVID-19 & Flu test, the first over-the-counter, at-home diagnostic test that can differentiate and detect influenza A and B, as well as SARS-CoV-2.
Chembio Diagnostics has obtained a CLIA waiver from the US Food and Drug Administration for its DPP HIV-Syphilis System, the firm announced on Friday.
China has been reopened. The world’s second largest economy, which plays an important role in accelerating domestic economic recovery as well as boosting global growth, has now completely removed mandatory quarantine and international flight limitations.
The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Mologic's over-the-counter SARS-CoV-2 antigen test.
Spectrum Solutions announced the U.S. Food and Drug Administration (FDA) has granted 510(k) Class II clearance to the SDNA Saliva Collection Device as a microbial nucleic acid storage and stabilization device.
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