Inventiva announces FDA decision that fast track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis

21 September 2021 - Inventiva today announced that the U.S. FDA has decided that the fast track designation previously granted to ...

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Aveo Oncology announces ficlatuzumab granted fast track designation by the U.S. FDA for the treatment of relapsed or recurrent head and neck squamous cell carcinoma

20 September 2021 - Aveo Oncology today announced that the U.S. FDA has granted fast frack designation to ficlatuzumab for the ...

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BridgeBio Pharma receives FDA fast track designation for investigational therapy for the treatment of limb-girdle muscular dystrophy type 2i (LGMD2i)

15 September 2021 - If successful, BridgeBio's drug could be the first approved therapy for patients with LGMD2i. ...

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Sage Therapeutics receives fast track designation for SAGE-718 for the treatment of Huntington’s disease

15 September 2021 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-718 for development ...

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Pulmocide’s lead drug candidate opelconazole (PC945) granted orphan drug, fast track and qualified infectious disease product designations by US FDA

15 September 2021 - Pulmocide today announced that the US FDA has granted orphan drug, fast track and qualified infectious disease ...

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ISA Pharmaceuticals receives fast track designation for lead product ISA101b

14 September 2021 - Fast track designation for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer to improve ...

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VOR33 granted U.S. FDA fast track designation for AML

9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...

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Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations

9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...

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HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU

8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...

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Novartis gets FDA fast track designation for LNA043 in knee osteoarthritis

2 September 2021 - Novartis AG on Thursday said the U.S. FDA granted fast track designation to LNA043 for the ...

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Humanetics Corporation’s BIO 300 receives fast track designation from FDA

24 August 2021 - Humanetics announced today that BIO 300, a drug under development to increase survival in persons exposed to ...

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Senhwa's silmitasertib receives US FDA fast track designation for the treatment of recurrent sonic hedgehog driven medulloblastoma

19 August 2021 - Senhwa Biosciences today announced that the US FDA has granted fast track designation for silmitasertib, a highly ...

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Sutro Biopharma announces STRO-002 FDA fast track designation for patients with advanced ovarian cancer

18 August 2021 - Sutro Biopharma today announced that the U.S. FDA has granted fast track designation for STRO-002, a folate ...

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Edgewise receives U.S. FDA fast track designation for EDG-5506 for the treatment of individuals with Becker muscular dystrophy

16 August 2021 - EDG-5506, a drug candidate designed to arrest muscle fibre breakdown in Becker and Duchenne muscular dystrophy, continues to ...

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Carrick Therapeutics receives FDA fast track designations for two samuraciclib combinations for the treatment of HR+, HER2- advanced breast cancer and locally advanced or metastatic triple negative breast cancer

16 August 2021 - Carrick Therapeutics today announced that the U.S. FDA has granted Fast Track designations to samuraciclib in combination ...

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