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RSS FeedPosted by Michael Wonder on 19 Jul 2022
Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease
19 July 2022 - The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in ...
Posted by Michael Wonder on 18 Jul 2022
Celcuity announces FDA breakthrough therapy designation for gedatolisib for treatment of HR positive, HER2 negative metastatic breast cancer
18 July 2022 - Celcuity today announced that the U.S. FDA has granted gedatolisib breakthrough therapy designation for the treatment of ...
Posted by Michael Wonder on 17 Jul 2022
China CDE grants breakthrough therapy designation to Neurophth's NR082 in Leber's hereditary optic neuropathy
15 July 2022 - Neurophth Therapeutics today announced that the Center for Drug Evaluation of China National Medical Products Administration has ...
Posted by Michael Wonder on 13 Jul 2022
Ancora Heart receives breakthrough device designation from FDA for the AccuCinch ventricular restoration system
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...
Posted by Michael Wonder on 13 Jul 2022
Abbott receives FDA breakthrough device designation to explore use of deep brain stimulation to manage severe depression
12 July 2022 - Each year, 2.8 million Americans will fail multiple depression therapies and be diagnosed with treatment-resistant depression. ...
Posted by Michael Wonder on 11 Jul 2022
T2 Biosystems receives FDA breakthrough device designation for the T2Lyme panel
11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...
Posted by Michael Wonder on 11 Jul 2022
US FDA grants Spectral Medical breakthrough device designation for Toraymyxin for the treatment of endotoxemic septic shock
11 July 2022 - Breakthrough designation expected to help accelerate regulatory review. ...
Posted by Michael Wonder on 29 Jun 2022
Janssen announces U.S. FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma
29 June 2022 - Novel GPRC5DxCD3 bispecific antibody receives breakthrough therapy designation based upon results from the Phase 1/2 MonumenTAL-1 study. ...
Posted by Michael Wonder on 23 Jun 2022
FDA explains when it will rescind breakthrough designations
23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...
Posted by Michael Wonder on 22 Jun 2022
FDA grants breakthrough device designation to VR mental illness treatment
22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...
Posted by Michael Wonder on 12 Jun 2022
Zai Lab announces breakthrough therapy designations granted for repotrectinib in China
10 June 2022 - Breakthrough therapy designations granted for ROS1 positive non-small-cell lung cancer patients pretreated with one prior line of ...
Posted by Michael Wonder on 12 Jun 2022
NRx Pharmaceuticals provides update on breakthrough therapy designation request for Zyesami (aviptadil)
10 June 2022 - NRx Pharmaceuticals today announced that the U.S. FDA denied the breakthrough therapy designation request for Zyesami (aviptadil) ...
Posted by Michael Wonder on 08 Jun 2022
Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA
8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...
Posted by Michael Wonder on 01 Jun 2022
FDA grants efanesoctocog alfa breakthrough therapy designation for haemophilia A
1 June 2022 - Designation is based on XTEND-1 Phase 3 study data demonstrating a clinically meaningful prevention of bleeds and ...
Posted by Michael Wonder on 31 May 2022
Timber Pharmaceuticals receives FDA breakthrough therapy designation for TMB-001 for the treatment of congenital ichthyosis
31 May 2022 - Company preparing to dose first patients in pivotal Phase 3 ASCEND clinical trial. ...