Blog
RSS FeedPosted by Michael Wonder on 18 Oct 2023
FloBio receives FDA's breakthrough device designation for bleeding risk diagnostic test
17 October 2023 - Rapid detection of modern blood thinners could reduce preventable complications in US hospitals. ...
Posted by Michael Wonder on 08 Sep 2023
Inovio announces US FDA breakthrough therapy designation granted for INO-3107 for the treatment of recurrent respiratory papillomatosis
7 September 2023 - Designation based on clinical evidence indicating INO-3107 may demonstrate substantial improvement over existing therapies. ...
Posted by Michael Wonder on 31 Aug 2023
Enhertu granted two breakthrough therapy designations in US for patients across multiple HER2 expressing cancers
31 August 2023 - Designations for Daiichi Sankyo and AstraZeneca's Enhertu include patients with HER2 expressing metastatic solid tumours and ...
Posted by Michael Wonder on 30 Aug 2023
Zai Lab announces breakthrough therapy designation granted for repotrectinib for treatment of patients with NTRK positive TKI-pretreated advanced solid tumours in China
30 August 2023 - Candidate precision medicine has shown encouraging clinical activity for both ROS1 positive NSCLC and NTRK fusion-positive advanced ...
Posted by Michael Wonder on 12 Aug 2023
Jacobio Pharma announces breakthrough therapy designation from China CDE for KRAS G12C inhibitor glecirasib for the treatment of pancreatic cancer
7 August 2023 - Jacobio Pharma today announced that Jacobio's in house KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation ...
Posted by Michael Wonder on 27 Jul 2023
FDA grants breakthrough therapy designation to NS-089/NCNP-02 for the treatment of Duchenne muscular dystrophy
27 July 2023 - NS Pharma announced today the US FDA has granted breakthrough therapy designation to NS-089/NCNP-02, an investigational ...
Posted 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 ...