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RSS FeedPosted 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. ...
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 ...
Posted by Michael Wonder on 04 May 2022
X-Therma receives FDA breakthrough device designation for XT-ViVo preservation solution and TimeSeal organ transport device
3 May 2022 - X-Therma announced today that the Center for Devices and Radiological Health of the FDA has granted ...
Posted by Michael Wonder on 04 May 2022
Mirvie receives FDA breakthrough device designation for first test designed to indicate risk of preeclampsia months before symptoms occur
3 May 2022 - Breakthrough has the potential to address a leading cause of maternal mortality that impacts millions of ...
Posted by Michael Wonder on 04 May 2022
SeaStar Medical granted FDA breakthrough device designation for a novel immunomodulatory therapy for acute kidney injury patients
3 May 2022 - Designation helps enable accelerated regulatory review of up-coming pivotal clinical trial for treatment in adult patients with ...