FDA grants breakthrough therapy designation for Dizal Pharmaceutical's DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harbouring EGFR Exon 20 insertion

27 January 2022 - Breakthrough therapy designation further demonstrates excellent clinical profile of DZD9008 (sunvozertinib). ...

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Magnesium Development Company announces FDA breakthrough device designation for resorbable HC screw

24 January 2022 - Magnesium Development Company's fixation solution, the HC Screw, has received the FDA’s breakthrough device designation, having exceeded ...

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Cook Medical receives FDA breakthrough designation for new drug eluting stent

21 January 2022 - Cook Medical has received breakthrough device designation from the US FDA on a new drug eluting stent ...

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Pathogenomix granted FDA breakthrough device designation

19 January 2022 - Patho-Seq uses next generation sequencing to rapidly identify bacteria from human samples during dangerous and life-threatening ...

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Sensydia receives FDA breakthrough device designation for CPS non-invasive cardiac monitoring device

19 January 2022 - Sensydia today announced that its cardiac performance system has been granted breakthrough device designation by the United ...

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FDA grants breakthrough device designation to Diadem's AlzoSure predict prognostic blood test for the early prediction of Alzheimer's disease

18 January 2022 - First prognostic blood test that can predict likely progression to Alzheimer's disease up to six years in ...

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NeuroMetrix receives FDA breakthrough device designation for treatment of chronic chemotherapy induced peripheral neuropathy with its wearable neurostimulation technology

18 January 2022 - NeuroMetrix today announced that its Quell technology has received breakthrough designation from the U.S. FDA for reducing ...

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FDA grants breakthrough therapy designation for Cullinan Oncology’s CLN-081 in patients with locally advanced or metastatic EGFR mutated non-small-cell lung cancer

4 January 2022 - Cullinan Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for CLN-081 for ...

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AbbVie announces U.S. FDA granted breakthrough therapy designation to telisotuzumab vedotin for previously treated non-small-cell lung cancer

4 January 2022 - There are currently no approved cancer therapies specifically for patients with c-Met overexpressing non-small-cell lung cancer. ...

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Patritumab deruxtecan granted U.S. FDA breakthrough therapy designation in patients with metastatic EGFR mutated non-small-cell lung cancer

23 December 2021 - First breakthrough therapy designation for patritumab deruxtecan based on results of Phase 1 trial. ...

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Fist Assist Devices receives FDA “breakthrough device” designation for the world’s first wearable vein dilation device for ESRD patients

16 December 2021 - Indication for pre-surgical vein dilation use to promote AV fistula creation. ...

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InterVene’s BlueLeaf Endovenous Valve Formation System granted breakthrough device designation by the FDA

13 December 2021 - InterVene announced today that it has received breakthrough device designation by the FDA for the company’s BlueLeaf ...

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Cytokinetics announces receipt of breakthrough therapy designation from FDA for aficamten

9 December 2021 - FDA granted designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy Based on results of REDWOOD-HCM. ...

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Linus Biotechnology receives FDA breakthrough device designation for StrandDx-ASD exposome sequencing diagnostic

7 December 2021 - Linus Biotechnology  today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health ...

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RefleXion receives breakthrough device designation for lung cancer treatment

1 December 2021 - RefleXion Medical today announced that the U.S. FDA has granted the company breakthrough device designation for ...

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