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RSS FeedPosted by Michael Wonder on 05 Dec 2023
Johnson & Johnson's investigational TAR-200 granted US FDA breakthrough therapy designation for the treatment of high risk non-muscle invasive bladder cancer
4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 17 Nov 2023
Palvella Therapeutics announces US FDA breakthrough therapy designation granted to Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) for the treatment of microcystic lymphatic malformations
16 November 2023 - Qtorin rapamycin has potential to be first approved therapy and standard of care in the US for ...
Posted by Michael Wonder on 02 Nov 2023
Nectero Medical granted breakthrough therapy designation for the Nectero EAST system to treat infrarenal AAA
1 November 2023 - Phase 2/3 clinical trial to initiate enrolment in Q4, 2023. ...
Posted by Michael Wonder on 31 Oct 2023
HI-Bio announces felzartamab granted breakthrough therapy designation by US Food and Drug Administration for primary membranous nephropathy
31 October 2023 - Human Immunology Biosciences today announced that the US FDA has granted breakthrough therapy designation for felzartamab in ...
Posted by Michael Wonder on 30 Oct 2023
ArriVent receives FDA breakthrough therapy designation for furmonertinib for first-line treatment of advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
30 October 2023 - ArriVent Biopharma today announced that the US FDA has granted breakthrough therapy designation for furmonertinib for ...
Posted 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 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 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 ...