Anumana receives US FDA breakthrough device designation for its cardiac amyloidosis algorithm

21 June 2023 - Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid ...

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Precigen receives breakthrough therapy designation for PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis

20 June 2023 - Designation based on positive Phase 1 clinical data that showed 50% of patients were "surgery-free" (Complete ...

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Grünenthal's resiniferatoxin receives breakthrough therapy designation from US FDA for pain associated with osteoarthritis of the knee

22 May 2023 - Grünenthal is running a global Phase III programme to investigate the efficacy and safety of intra-articular injections ...

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Innovent receives NMPA breakthrough designation for IBI351 (KRASG12C inhibitor) as monotherapy for previously treated advanced colorectal carcinoma

15 May 2023 - Innovent Biologics announced that the Center for Drug Evaluation of China’s National Medical Products Administration has granted ...

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US FDA grants breakthrough therapy designation for spesolimab for the prevention of flares in adults with generalised pustular psoriasis

2 May 2023 - Breakthrough therapy designation is supported by results from the Effisayil 2 trial which studied spesolimab in the ...

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SAB Biotherapeutics announces US FDA grants breakthrough therapy designation to SAB-176 influenza immunotherapy

18 April 2023 - SAB-176 has now received both breakthrough and fast track designations from FDA – signifying its potential to ...

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Madrigal receives breakthrough therapy designation from FDA for resmetirom

18 April 2023 - Madrigal Pharmaceuticals today announced that resmetirom has received breakthrough therapy designation from the US FDA for the ...

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Genetesis receives second FDA breakthrough device designation for non-invasive diagnosis of myocardial ischaemia using CardioFlux MCG

13 April 2023 - Designation represents progress for patients with suspected coronary microvascular dysfunction as the FDA recognises disease’s debilitating impacts ...

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Reach Neuro receives FDA breakthrough device designation for device to restore arm and hand movement to chronic stroke patients

10 April 2023 - Reach Neuro's Avantis device delivers small electrical impulses to the spinal cord to help stroke survivors ...

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Pixium Vision announces FDA breakthrough device designation for the Prima System in dry AMD

31 March 2023 - PRIMAvera European pivotal trial in dry AMD fully recruited and on track to report primary endpoints around ...

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FDA grants breakthrough device designation to Aural Analytics for speech analytics software to be used in treatment of ALS

29 March 2023 - Aural Analytics today announced that its Speech Vitals - ALS technology has been granted designation as ...

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Deciphera Pharmaceuticals announces FDA grants breakthrough therapy designation for Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18

14 March 2023 - Breakthrough therapy designation is based on results from ctDNA analysis of INTRIGUE Phase 3 clinical trial demonstrating ...

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Sooma Medical receives FDA breakthrough device designation for its innovative at home depression treatment device

6 March 2023 - Sooma Medical has been granted breakthrough device designation by the US FDA for its portable, patient-administered ...

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Boomerang Medical earns FDA breakthrough device designation

1 March 2023 - Boomerang Medical is currently enrolling a clinical trial studying a bioelectronic device for people living with Crohn’s ...

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Moderna and Merck announce mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with pembrolizumab, was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection

22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. ...

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