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. ...

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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23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...

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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 ...

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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 ...

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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) ...

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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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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VenoStent technology receives breakthrough device designation by FDA

17 May 2022 - Designation to promote more rapid agency and market access for VenoStent. ...

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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 ...

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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 ...

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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 ...

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