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RSS FeedPosted by Michael Wonder on 31 May 2017
ProQR receives fast track designation from the FDA for QR-110 for Leber’s congenital amaurosis type 10
31 May 2017 - QR-110 is currently in clinical development with the planned Phase 1/2 open-label trial (PQ-110-001) that will assess ...
Posted by Michael Wonder on 30 May 2017
AMO Pharma announces FDA fast track designation for AMO-02 for treatment of congenital myotonic dystrophy
30 May 2017 - AMO Pharma Limited today announced that the U.S. FDA has granted fast track designation for AMO-02, the ...
Posted by Michael Wonder on 30 May 2017
jCyte receives regenerative medicine advanced therapy designation
2 May 2017 - Cell therapy company jCyte announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 29 May 2017
Athersys announces fast track designation by FDA for stroke program and other progress
9 May 2017 - Athersys today announced its financial results for the three months ended 31 March 2017. ...
Posted by Michael Wonder on 26 May 2017
CalciMedica receives fast-track designation for CM4620, a novel CRAC channel inhibitor to treat acute pancreatitis
24 May 2017 - Patient studies expected to begin in 2018. ...
Posted by Michael Wonder on 19 May 2017
Sage Therapeutics receives fast track designation for SAGE-217 for the treatment of major depressive disorder
18 May 2017 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-217 for ...
Posted by Michael Wonder on 17 May 2017
Sangamo receives fast track designation from the FDA for SB-525 investigational haemophilia A gene therapy
16 May 2017 - Sangamo Therapeutics announced today that the U.S. FDA has granted fast track designation to SB-525, the Company's ...
Posted by Michael Wonder on 16 May 2017
Biohaven's trigriluzole receives fast track designation from U.S. FDA
15 May 2017 - Potential first-in-class therapy for spinocerebellar ataxia. ...
Posted by Michael Wonder on 12 May 2017
Oncolytics Biotech announces FDA fast track designation for Reolysin in metastatic breast cancer
8 May 2017 - Oncolytics Biotech announced today that the United States FDA has granted fast track designation for Reolysin, the ...
Posted by Michael Wonder on 12 May 2017
Vericel receives FDA regenerative medicine advanced therapy designation for ixmyelocel-T for the treatment of advanced heart failure due to ischaemic dilated cardiomyopathy
10 May 2017 - Ixmyelocel-T is the first therapy to receive the RMAT designation for the treatment of a serious ...
Posted by Michael Wonder on 12 May 2017
FDA grants fast track designation for Celyad’s ischemic heart failure therapy, C-Cure
11 May 2017 - Designation granted on the strength of the evidence in the subset of patients that were responders ...
Posted by Michael Wonder on 09 May 2017
FDA grants fast track designation to XyloCor Therapeutics lead candidate XC001
8 May 2017 - XyloCor Therapeutics announced that the U.S. FDA has granted fast track designation to its lead product candidate ...
Posted by Michael Wonder on 09 May 2017
Axsome Therapeutics receives FDA fast track designation for AXS-05 for Alzheimer’s disease agitation
8 May 2017 - Axsome Therapeutics received fast track designation from the U.S. FDA for AXS-05 for the treatment of agitation ...
Posted by Michael Wonder on 05 May 2017
Sangamo Therapeutics announces special regulatory designations from the FDA for three clinical programs
4 May 2017 - Fast track designation for SB-FIX in vivo genome editing treatment for haemophilia B. ...
Posted by Michael Wonder on 03 May 2017
Altor BioScience Corporation announces FDA fast track designation for lead candidate ALT-803 in patients with non-muscle invasive bladder cancer
2 May 2017 - Altor BioScience announced today that it has received fast track designation from the US FDA for its ...