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RSS FeedPosted by Michael Wonder on 18 May 2019
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 ...
Posted by Michael Wonder on 15 May 2019
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 ...
Posted by Michael Wonder on 14 May 2019
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. ...
Posted by Michael Wonder on 08 May 2019
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 ...
Posted by Michael Wonder on 07 May 2019
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 ...
Posted by Michael Wonder on 07 May 2019
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 ...
Posted by Michael Wonder on 01 May 2019
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 ...
Posted by Michael Wonder on 30 Apr 2019
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 ...
Posted by Michael Wonder on 23 Apr 2019
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 ...
Posted by Michael Wonder on 21 Apr 2019
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 ...
Posted by Michael Wonder on 17 Apr 2019
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. ...
Posted by Michael Wonder on 17 Apr 2019
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 ...
Posted by Michael Wonder on 16 Apr 2019
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 ...
Posted by Michael Wonder on 09 Apr 2019
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. ...
Posted by Michael Wonder on 09 Apr 2019
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. ...