Cybin receives FDA breakthrough therapy designation for its novel psychedelic molecule CYB003

13 March 2024 -  First known breakthrough therapy designation granted by the FDA for an adjunctive psychedelic based therapy for the ...

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MindMed receives FDA breakthrough therapy designation for MM120 for generalized anxiety disorder

7 March 2024 - Mind Medicine today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for ...

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Nuvalent receives US FDA breakthrough therapy designation for NVL-520

27 February 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-520 for the ...

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Bayer receives US FDA breakthrough therapy designation for BAY 2927088 for non-small-cell lung cancer harbouring HER2 activating mutations

26 February 2024 - BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor under development as a potential new targeted ...

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Sibeprenlimab received US FDA breakthrough therapy designation for the treatment of immunoglobulin A nephropathy

16 February 2024 - Otsuka and Visterra announce that the US FDA has granted breakthrough therapy designation for the investigational drug ...

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RadioMedix and Orano Med receive FDA breakthrough therapy designation for AlphaMedix in gastro-enteropancreatic neuroendocrine tumours

12 February 2024 - First targeted alfa therapy to receive a breakthrough therapy designation. ...

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Johnson & Johnson's nipocalimab granted US FDA breakthrough therapy designation for the treatment of individuals at high risk for severe haemolytic disease of the foetus and newborn

9 February 2024 - Breakthrough therapy designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for haemolytic ...

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FDA grants latozinemab breakthrough therapy designation for frontotemporal dementia due to a progranulin gene mutation

7 February 2024 - Latozinemab is the most advanced progranulin-elevating candidate in development for frontotemporal dementia with a progranulin gene mutation ...

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Ensysce Biosciences announces FDA breakthrough therapy designation granted for PF614-MPAR

23 January 2024 - FDA acknowledges significant potential impact of MPAR's oral overdose protection. ...

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BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody drug conjugate candidate BNT323/DB-1303 in endometrial cancer

21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...

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Neurocrine Biosciences receives breakthrough therapy designation from US FDA for crinecerfont in congenital adrenal hyperplasia

5 December 2023 - Crinecerfont new drug application submission planned in 2024. ...

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Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee

5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...

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CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high risk BCG unresponsive non-muscle invasive bladder cancer

5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...

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Johnson & Johnson's investigational TAR-200 granted US FDA breakthrough therapy designation for the treatment of high risk non-muscle invasive bladder cancer

4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 ...

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AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma

27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...

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