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RSS FeedPosted by Michael Wonder on 21 Jul 2023
HUTCHMED receives breakthrough therapy designation in China for fruquintinib combination with sintilimab for treatment of advanced endometrial cancer
19 July 2023 - HUTCHMED today announces that the Center for Drug Evaluation of China’s NMPA has granted breakthrough therapy ...
Posted by Michael Wonder on 20 Jul 2023
T2 Biosystems receives FDA breakthrough device designation for Candida auris diagnostic test
20 July 2023 - T2 Biosystems announced today the US FDA has granted breakthrough device designation for the Company’s Candida auris ...
Posted by Michael Wonder on 12 Jul 2023
Renibus Therapeutics announces breakthrough therapy designation from US FDA for RBT-1 for the reduction in risk of post-operative complications in patients undergoing cardiothoracic surgery
11 July 2023 - RBT-1 is a first in class, pre-conditioning drug in the cardiothoracic surgery setting. ...
Posted by Michael Wonder on 29 Jun 2023
Zenocutuzumab granted breakthrough therapy designation by the US FDA for the treatment of NRG1+ pancreatic cancer
29 June 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for zenocutuzumab for the ...
Posted by Michael Wonder on 22 Jun 2023
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 ...
Posted by Michael Wonder on 20 Jun 2023
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 ...
Posted by Michael Wonder on 23 May 2023
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 ...
Posted by Michael Wonder on 16 May 2023
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 ...
Posted by Michael Wonder on 11 May 2023
Lawmakers press CMS to release new breakthrough device coverage rule
10 May 2023 - An array of lawmakers called for a simpler reimbursement pathway for breakthrough devices at a Ways and ...
Posted by Michael Wonder on 03 May 2023
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 ...
Posted by Michael Wonder on 19 Apr 2023
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 ...
Posted by Michael Wonder on 19 Apr 2023
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 ...
Posted by Michael Wonder on 14 Apr 2023
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 ...
Posted by Michael Wonder on 12 Apr 2023
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 ...
Posted by Michael Wonder on 02 Apr 2023
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 ...