Alector announces FDA fast track designation granted to AL001 for the treatment of patients with frontotemporal dementia

5 December 2019 - Alector today announced that the U.S. FDA has granted fast track designation for its investigational therapeutic, ...

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Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome

18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) ...

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Seelos Therapeutics receives FDA fast track designation for intranasal racemic ketamine (SLS-002)

18 November 2019 - Seelos Therapeutics today announced the U.S. FDA has granted fast track designation to its new, investigational intranasal ...

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Viracta receives fast track designation for nanatinostat combination for the treatment of EBV-associated lymphomas

12 November 2019 - Viracta Therapeutic, announced today that the U.S. FDA has granted fast track designation for nanatinostat in ...

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Triumvira Immunologics announces fast track designation for its first TAC T-Cell therapeutic product candidate: TAC01-CD19

7 November 2019 - Designation confirms significant unmet need remains in DLBCL. ...

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EIP Pharma announces U.S. FDA grants fast-track designation to neflamapimod as a treatment for dementia with Lewy Bodies

7 November 2019 -  EIP Pharma today announced that the Division of Neurology Products of the U.S. FDA has granted ...

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Bionomics announces fast track designation granted by U.S. FDA to BNC210 development program for the treatment of PTSD

4 November 2019 - Bionomics announced today that the U.S. FDA has granted fast track designation to the BNC210 development program ...

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Terns Pharmaceuticals receives fast track designation from the FDA for TERN-101, an FXR agonist for the treatment of NASH

29 October 2019 - Terns Pharmaceuticals today announced that TERN-101, an investigational farnesoid X receptor (FXR) agonist, has been granted fast ...

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U.S. FDA grants fast track designation to Astellas for the development of ASP1128 for patients at risk for acute kidney injury

28 October 2019 - Astellas Pharma today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...

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Moderna receives FDA fast track designation for propionic acidemia program (mRNA-3927)

22 October 2019 - mRNA-3927 is Moderna’s second rare disease program to receive fast track designation. ...

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BerGenBio receives FDA approval of fast track designation for bemcentinib

22 October 2019 - BerGenBio today announces that the U.S FDA has approved fast track designation for bemcentinib for the treatment ...

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Xenikos receives FDA fast track designation for T-Guard(R) for treating steroid-refractory acute graft-versus-host disease

14 October 2019 - Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial. ...

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FDA grants FX-322 fast track designation

10 October 2019 - The company also announced today that the U.S. FDA has granted fast track designation for FX-322.  ...

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Mereo BioPharma receives FDA fast track designation for navicixizumab for the treatment of heavily pre-treated ovarian cancer

7 October 2019 - Mereo BioPharma  today announces that the U.S. FDA has granted fast track designation to navicixizumab for the ...

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Geron announces fast track designation granted to imetelstat for relapsed/refractory myelofibrosis

30 September 2019 - Geron Corporation today announced that the United States FDA has granted fast track designation to imetelstat for ...

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