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RSS FeedPosted by Michael Wonder on 27 Jan 2022
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). ...
Posted by Michael Wonder on 25 Jan 2022
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 ...
Posted by Michael Wonder on 24 Jan 2022
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 ...
Posted by Michael Wonder on 20 Jan 2022
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 ...
Posted by Michael Wonder on 19 Jan 2022
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 ...
Posted by Michael Wonder on 19 Jan 2022
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 ...
Posted by Michael Wonder on 19 Jan 2022
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 ...
Posted by Michael Wonder on 05 Jan 2022
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 ...
Posted by Michael Wonder on 04 Jan 2022
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. ...
Posted by Michael Wonder on 26 Dec 2021
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. ...
Posted by Michael Wonder on 19 Dec 2021
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. ...
Posted by Michael Wonder on 13 Dec 2021
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 ...
Posted by Michael Wonder on 10 Dec 2021
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. ...
Posted by Michael Wonder on 07 Dec 2021
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 ...
Posted by Michael Wonder on 05 Dec 2021
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 ...