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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Palvella Therapeutics announces US FDA breakthrough therapy designation granted to Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) for the treatment of microcystic lymphatic malformations

16 November 2023 - Qtorin rapamycin has potential to be first approved therapy and standard of care in the US for ...

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Nectero Medical granted breakthrough therapy designation for the Nectero EAST system to treat infrarenal AAA

1 November 2023 - Phase 2/3 clinical trial to initiate enrolment in Q4, 2023. ...

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HI-Bio announces felzartamab granted breakthrough therapy designation by US Food and Drug Administration for primary membranous nephropathy

31 October 2023 - Human Immunology Biosciences today announced that the US FDA has granted breakthrough therapy designation for felzartamab in ...

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ArriVent receives FDA breakthrough therapy designation for furmonertinib for first-line treatment of advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

30 October 2023 - ArriVent Biopharma today announced that the US FDA has granted breakthrough therapy designation for furmonertinib for ...

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