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RSS FeedPosted by Michael Wonder on 26 Oct 2023
US FDA grants Paige breakthrough device designation for cancer detection in breast lymph nodes
26 October 2023 - Paige announced today that the US FDA has granted breakthrough device designation for Paige Lymph Node, an ...
Posted by Michael Wonder on 24 Oct 2023
Bristol Myers Squibb announces US FDA breakthrough therapy designation for investigational LPA1 antagonist for progressive pulmonary fibrosis
24 October 2023 - Designation is based on results from the progressive pulmonary fibrosis cohort of the Phase 2 study ...
Posted by Michael Wonder on 23 Oct 2023
Seladelpar granted revised breakthrough therapy designation for the treatment of primary biliary cholangitis including pruritus in patients without cirrhosis or with compensated cirrhosis
23 October 2023 - CymaBay Therapeutics today announced that the US FDA has revised the originally granted breakthrough therapy designation for ...
Posted by Michael Wonder on 19 Oct 2023
FDA Grants SeaStar Medical’s selective cytopheretic device breakthrough device designation for hepatorenal syndrome
18 October 2023 - SeaStar Medical announces receipt of US FDA breakthrough device designation for its patented, first in class, ...
Posted 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 ...