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RSS FeedPosted 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23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...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
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. ...
Posted by Michael Wonder on 27 May 2022
FDA grants breakthrough device designation for Emily's Care Nourish Test System
26 May 2022 - Lactation Lab has announced today that the U.S. FDA, has granted the company breakthrough device designation ...
Posted by Michael Wonder on 24 May 2022
FDA grants breakthrough device designation to Anumana’s ECG pulmonary hypertension early detection AI algorithm
24 May 2022 - Anumana today announced that the U.S. FDA has granted breakthrough device designation to its AI-enhanced, ECG based ...
Posted by Michael Wonder on 18 May 2022
Exactech announces FDA breakthrough device designation for JointMedica’s Polymotion hip resurfacing system
17 May 2022 - Exactech announced that the U.S. FDA has granted a breakthrough device designation for JointMedica’s Polymotion hip ...
Posted by Michael Wonder on 18 May 2022
VenoStent technology receives breakthrough device designation by FDA
17 May 2022 - Designation to promote more rapid agency and market access for VenoStent. ...
Posted by Michael Wonder on 12 May 2022
FDA grants breakthrough device designation to Remedee Labs for its groundbreaking endorphin stimulation solution for the management of fibromyalgia
12 May 2022 - On World Fibromyalgia Awareness Day (May 12), the French startup Remedee Labs is announcing that the FDA ...
Posted by Michael Wonder on 12 May 2022
Wysa receives FDA breakthrough device designation for AI led mental health conversational agent
12 May 2022 - New peer-reviewed studies demonstrate efficacy in managing chronic pain, depression and anxiety ...
Posted by Michael Wonder on 10 May 2022
Turning Point Therapeutics granted breakthrough therapy designation for repotrectinib treatment in patients with one prior ROS1 tyrosine kinase inhibitor and no prior chemotherapy
10 May 2022 - Turning Point Therapeutics today announced the U.S. FDA granted an eighth regulatory designation, and third breakthrough therapy ...