Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation

16 December 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) for ...

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Galderma investigational therapy nemolizumab granted FDA breakthrough therapy designation for the treatment of patients suffering from prurigo nodularis

9 December 2019 - Galderma today announced that the U.S. FDA has granted breakthrough therapy Designation to the investigational therapy ...

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Janssen announces BCMA CAR-T therapy JNJ-4528 granted U.S. FDA breakthrough therapy designation for the treatment of relapsed or refractory multiple myeloma

6 December 2019 - Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory ...

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ImmunityBio granted FDA breakthrough therapy designation for N-803 IL-15 superagonist in non-muscle invasive bladder cancer

4 December 2019 - Results of Phase 1 and 2 studies in BCG unresponsive non-muscle invasive bladder cancer in high risk ...

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Bristol-Myers Squibb announces U.S. FDA breakthrough therapy designation for Orencia (abatacept) to help prevent acute graft-versus-host disease, a potentially life-threatening complication after stem cell transplant

4 December 2019 - Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for Orencia (abatacept) ...

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FDA grants breakthrough therapy designation to Usona Institute's psilocybin program for major depressive disorder

22 November 2019 - Usona Institute has received breakthrough therapy designation from the US FDA for psilocybin in the treatment ...

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Kiniksa announces breakthrough therapy designation for rilonacept for the treatment of recurrent pericarditis

20 November 2019 - Kiniksa Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation for rilonacept for the ...

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Orphazyme receives breakthrough therapy designation for arimoclomol in Niemann-Pick disease Type C

19 November 2019 - Orphazyme today announces that the US FDA has granted breakthrough therapy designation for arimoclomol, an investigational drug ...

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X4 Pharmaceuticals receives breakthrough therapy designation from the FDA for mavorixafor for the treatment of WHIM syndrome

12 November 2019 - X4 Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for mavorixafor (X4P-001) ...

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U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for patients with previously treated advanced hepatocellular carcinoma

11 November 2019 - The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication. ...

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F2G receives US FDA breakthrough therapy designation for Olorofim

11 November 2019 - First anti-fungal agent to receive breakthrough therapy designation. ...

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Mirum Pharmaceuticals announces breakthrough therapy designation for maralixibat for the treatment of pruritus associated with Alagille syndrome

28 October 2019 - Mirum Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for maralixibat for the ...

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FDA approves new breakthrough therapy for cystic fibrosis

21 October 2019 - Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic ...

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FDA grants breakthrough therapy designation to cobimetinib for MEK inhibition in histiocytic neoplasms, research led by MSK

2 October 2019 - Memorial Sloan Kettering Cancer Center announced today that the US FDA has granted a breakthrough therapy designation ...

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Janssen announces U.S. FDA breakthrough therapy designation granted for niraparib for the treatment of metastatic castration-resistant prostate cancer

3 October 2019 - Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant ...

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