Athersys announces fast track designation from FDA for MultiStem program for acute respiratory distress syndrome

14 May 2019 - Athersys announced today that its clinical program evaluating MultiStem cell therapy for the treatment of acute respiratory ...

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Homology Medicines announces FDA fast track designation for HMI-102 gene therapy development candidate for adults with PKU

14 May 2019 - Company provides details of pheNIX, the first gene therapy trial for PKU, and remains on track to ...

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Cellectar receives FDA fast track designation for CLR 131 in relapsed or refractory multiple myeloma

13 May 2019 - Designation could accelerate CLR 131 development and underscores the need for new treatments. ...

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FDA grants CytoDyn fast track designation for leronlimab (PRO 140) in metastatic triple-negative breast cancer, an unmet medical need

7 May 2019 - CytoDyn today announced that the U.S. FDA has granted fast track designation to leronlimab (PRO140) for ...

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Zynerba Pharmaceuticals receives fast track designation for Zygel for the treatment of behavioural symptoms associated with Fragile X syndrome

6 May 2019 - Enrolment progressing in pivotal CONNECT-FX trial of Zygel in Fragile X syndrome, with data expected in the ...

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Savara announces Molgradex received fast track designation by FDA for treatment of auto-immune pulmonary alveolar proteinosis

6 May 2019 - Savara today announced that the U.S. FDA granted fast track designation for Molgradex, an inhaled formulation ...

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Phoenix Tissue Repair receives FDA fast track designation for PTR-01 for the treatment of dystrophic epidermolysis bullosa

30 April 2019 - Phoenix Tissue Repair today announced that the U.S. FDA has granted fast track designation for PTR-01, an ...

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Finch Therapeutics receives fast track designation for the investigation of full-spectrum microbiota as a treatment for children with autism spectrum disorder

29 April 2019 - Finch Therapeutics announced today that the U.S. FDA has granted fast track designation to its full-spectrum microbiota ...

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Intensity Therapeutics receives fast track designation from U.S. FDA for development of INT230-6 as treatment for relapsed or metastatic triple negative breast cancer

17 April 2019 - Intensity Therapeutics today announced that the U.S. FDA has granted fast track designation to the Company’s ...

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Moleculin receives FDA approval of fast track designation for annamycin

18 April 2019 - Moleculin Biotech today announced that the U.S. FDA has approved its request for fast track designation ...

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Ultragenyx announces UX007 granted fast track designation and rare pediatric disease designation by U.S. FDA for treatment of long-chain fatty acid oxidation disorders

16 April 2019 - Company on track to submit NDA to FDA in mid 2019. ...

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CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of beta thalassemia

16 April 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated today announced that the U.S. FDA has granted fast track ...

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Aprea Therapeutics receives FDA fast track designation and orphan drug designation for APR-246 for the treatment of myelodysplastic syndromes

16 April 2019 - Aprea Therapeutics today announced that the U.S. FDA has granted fast track designation to APR-246 for ...

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PhaseBio receives FDA breakthrough therapy designation for PB2452 for the reversal of the anti-platelet activity of ticagrelor

8 April 2019 - In Phase 1 clinical trial, PB2452 provided immediate and sustained reversal of ticagrelor anti-platelet effects. ...

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uniQure receives FDA fast track designation for AMT-130 gene therapy for the treatment of Huntington’s disease

8 April 2019 - On track to treat first patient in Phase I/II study of AMT-130 in 2H19. ...

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