FDA grants Revalesio fast track status for ALS investigational drug RNS60

4 January 2019 - Revalesio announced today that the U.S. FDA granted fast track status for its investigational drug RNS60 as ...

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Rainier Therapeutics announces fast track designation granted by FDA for vofatamab in treatment of FGFR3-positive urothelial cell carcinoma

7 January 2019 - Rainier Therapeutics today announced that its targeted antibody vofatamab has received fast track designation from the U.S. ...

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CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of sickle cell disease

4 January 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for ...

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ImmusanT secures fast track designation for lead therapeutic vaccine candidate Nexvax2 for patients with celiac disease

2 January 2019 - Nexvax2 has been designed to potentially restore immune tolerance to gluten in patients with celiac disease. ...

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ProQR receives fast track designation from FDA for QR-421a for Usher Syndrome Type 2

2 January 2019 - ProQR Therapeutics today announced that it received fast track designation from the FDA for QR-421a.  ...

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BioXcel Therapeutics receives FDA fast track designation for BXCL501 for acute treatment of agitation

27 December 2018 - Fast track designation for BXCL501 will help facilitate anticipated registration trials in 2019 upon completion of pharmacokinetic ...

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Valneva awarded FDA fast track designation for Chikungunya vaccine candidate

21 December 2018 - Valneva announced today that the U.S. FDA has granted fast track designation for its chikungunya vaccine candidate, ...

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Gritstone Oncology announces FDA fast track designation for GRANITE-001 for the treatment of colorectal cancer

20 December 2018 - Gritstone Oncology today announced that the U.S. FDA has granted fast track designation to GRANITE-001 for the ...

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Equillium granted U.S. FDA fast track designation for EQ001 for the treatment of acute graft-versus-host disease

19 December 2018 - Company plans to initiate Phase 1b/2 EQUATE clinical trial in early 2019. ...

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FDA grants fast track designation to the baricitinib development program for the treatment of systemic lupus erythematosus

13 December 2018 - Eli Lilly and Incyte announced today that the U.S. FDA has granted fast track designation to ...

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Non-cystic fibrosis bronchiectasis FDA grants “fast-track” and “QIPD” to Zambon for colistimethate sodium powder for nebuliser solution delivered by the I-neb AAD system

11 December 2018 - Non–cystic fibrosis bronchiectasis is a, chronic, progressive and irreversible disease, prevalent in Europe and the US. ...

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Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of dry age-related macular degeneration with geographic atrophy

10 December 2018 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead investigational ...

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U.S. FDA grants fast track designation to Asana BioSciences’ oral dual JAK-SYK inhibitor, ASN002, for the treatment of atopic dermatitis

10 December 2018 - Asana BioSciences announced today that the U.S. FDA has granted fast track designation to Asana’s investigational oral ...

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FDA grants fast track designation for AMG 420

3 December 2018 - Amgen today announced the first clinical results from studies evaluating investigational novel bi-specific T cell engager (BiTE) ...

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Acceleron receives FDA fast track designation for ACE-083 in Charcot-Marie-Tooth disease

28 November 2018 - Acceleron Pharma today announced that the United States FDA has granted fast track designation to ACE-083, the ...

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