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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Achillion receives breakthrough therapy designation from FDA for danicopan for treatment of paroxysmal nocturnal hemoglobinuria

25 September 2019 - Achillion Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for danicopan (ACH-4471) for ...

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FDA grants breakthrough therapy designation for Roche’s Gazyva (obinutuzumab) in lupus nephritis

18 September 2019 - There are currently no U.S. FDA approved medicines for lupus nephritis. ...

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When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates

11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...

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Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations

11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan. ...

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Ridgeback Biotherapeutics announces receipt of breakthrough therapy designation from FDA for mAb114

6 September 2019 - Ridgeback Biotherapeutics today announced that the FDA has recently granted mAb114, an experimental treatment for Ebola, ...

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Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA breakthrough therapy designation for patients with MET-mutated advanced non-small cell lung cancer

6 September 2019 - Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019. ...

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Janssen announces U.S. FDA breakthrough therapy designation for investigational prophylactic vaccine for the prevention of respiratory syncytial virus in older adults

3 September 2019 - Janssen announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's investigational ...

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SpringWorks Therapeutics receives breakthrough therapy designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumours

29 August 2019 - SpringWorks Therapeutics today announced the U.S. FDA has granted breakthrough therapy designation for nirogacestat, an oral, selective, ...

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Eiger announces FDA breakthrough therapy designation for peginterferon lambda for treatment of hepatitis delta virus infection

20 August 2019 - Fourth Eiger program granted breakthrough therapy designation. ...

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