Blog
RSS FeedPosted by Michael Wonder on 26 Aug 2022
Stakeholders ask FDA to be more flexible on rescinding breakthrough drug designations
26 August 2022 - Pharmaceutical stakeholders want the US FDA to be more flexible when revoking breakthrough therapy designations. ...
Posted by Michael Wonder on 20 Aug 2022
Father invents balance treatment device for daughter; makes history with FDA clearance AND breakthrough device designation
18 August 2022 - GyroStim, a multi-axis rotational chair, was invented by a Colorado father in his garage to aid ...
Posted by Michael Wonder on 11 Aug 2022
The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers
11 August 2022 - The Breakthrough Device Program is approaching terminal velocity. ...
Posted by Michael Wonder on 04 Aug 2022
Travere Therapeutics provides regulatory updates on its development programs
3 August 2022 - Pegtibatinase granted breakthrough therapy designation by FDA. ...
Posted by Michael Wonder on 23 Jul 2022
Vertex advances VX-548 in acute and neuropathic pain
22 July 2022 - Breakthrough therapy designation granted by FDA. ...
Posted 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 ...