Jemperli (dostarlimab) receives US FDA breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer

16 December 2024 - Designation based on data showing no evidence of disease in 100% of all 42 patients who completed ...

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US FDA grants breakthrough therapy designation to Trodelvy (sacituzumab govitecan-hziy) for second-line treatment of extensive-stage small cell lung cancer

17 December 2024 - Gilead Sciences today announced that the US FDA has granted breakthrough therapy designation to Trodelvy (sacituzumab ...

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Tolebrutinib designated breakthrough therapy by the FDA for non-relapsing secondary progressive multiple sclerosis

13 December 2024 - Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple ...

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Stoke Therapeutics receives FDA breakthrough therapy designation for zorevunersen for the treatment of Dravet syndrome

4 December 2024 - Supported by evidence from clinical studies that indicate that zorevunersen may demonstrate substantial improvement over available therapies. ...

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Allay Therapeutics receives FDA breakthrough therapy designation for ATX101 for the treatment of post-surgical pain following total knee replacement surgery

4 December 2024 - Breakthrough therapy designation supported by results from a Phase 2 dose-ranging trial. ...

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Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta

12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...

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FDA grants breakthrough therapy designation to Seres Therapeutics’ SER-155 for reduction of bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplantation

9 December 2024 - Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk ...

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Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR mutated non-small cell lung cancer

9 December 2024 - First breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan based on TROPION-Lung05 Phase 2 ...

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FDA grants breakthrough therapy designation to sacituzumab tirumotecan for the treatment of certain patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations

3 December 2024 - First breakthrough therapy designation for investigational sac-TMT in the US. ...

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FDA grants breakthrough therapy designation to Huahui Health's libevitug (HH-003) for treatment of chronic hepatitis D virus infection

18 November 2024 - Huahui Health today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an ...

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Nipocalimab is the first and only investigational therapy granted US FDA breakthrough therapy designation for the treatment of adults living with moderate to severe Sjögren’s disease

11 November 2024 - The breakthrough therapy designation for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved ...

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Volixibat granted breakthrough therapy designation for cholestatic pruritus in primary biliary cholangitis

10 October 2024 - Designation based on positive interim analysis of Phase 2b VANTAGE study. ...

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Biogen receives US FDA breakthrough therapy designation for felzartamab for the treatment of antibody mediated rejection in kidney transplant recipients

9 October 2024 - Designation is based on data from the clinical development program which demonstrated clinical proof of concept. ...

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Boehringer receives US FDA breakthrough therapy designation and initiates two Phase 3 trials in MASH for survodutide

8 October 2024 - The US FDA breakthrough therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis ...

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Ultragenyx receives breakthrough therapy designation for setrusumab (UX143) in osteogenesis imperfecta

7 October 2024 - Ultragenyx today announced that it has received breakthrough therapy designation from the US FDA for setrusumab (UX143) ...

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