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RSS FeedPosted by Michael Wonder on 10 Dec 2018
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 ...
Posted by Michael Wonder on 10 Dec 2018
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 ...
Posted by Michael Wonder on 05 Dec 2018
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) ...
Posted by Michael Wonder on 29 Nov 2018
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 ...
Posted by Michael Wonder on 29 Nov 2018
Galapagos receives fast track designation from FDA for GLPG1972/S201086 in osteoarthritis
27 November 2018 - Galapagos announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of ...
Posted by Michael Wonder on 27 Nov 2018
HighTide Therapeutics receives fast track designation from the U.S. FDA for HTD1801 treating non-alcoholic steatohepatitis
27 November 2018 - HighTide Therapeutics announced that the U.S. FDA has granted fast track designation to its investigational new drug, ...
Posted by Michael Wonder on 14 Nov 2018
Palvella Therapeutics announces FDA fast track designation for PTX-022 for treatment of pachyonychia congenita
12 November 2018 - Palvella Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead product ...
Posted by Michael Wonder on 10 Nov 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma
7 November 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to selinexor, the Company’s ...
Posted by Michael Wonder on 07 Nov 2018
SpringWorks Therapeutics receives FDA fast track designation for nirogacestat for the treatment of adult patients with desmoid tumours
7 November 2018 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for nirogacestat, an investigational, ...
Posted by Michael Wonder on 02 Nov 2018
Constellation Pharmaceuticals receives FDA fast track designation for CPI-0610 in treatment of myelofibrosis
1 November 2018 - Recently expanded and enhanced MANIFEST Phase 2 trial on-going with proof of concept data expected mid-2019. ...
Posted by Michael Wonder on 18 Oct 2018
Albireo receives FDA fast track designation for A4250
17 October 2018 - Albireo Pharma today announced the U.S. FDA has granted Fast Track designation to lead product candidate ...
Posted by Michael Wonder on 04 Oct 2018
VistaGen Therapeutics receives FDA fast track designation for development of AV-101 as a non-opioid treatment for neuropathic pain
3 October 2018 - Second FDA fast track designation for AV-101 since December 2017 marks another milestone for VistaGen's R&D pipeline. ...
Posted by Michael Wonder on 01 Oct 2018
HighTide Therapeutics receives fast track designation from the U.S. FDA for HTD1801 treating primary sclerosing cholangitis
27 September 2018 - HighTide Therapeutics announced that the U.S. FDA has granted fast track designation to its investigational new drug, ...
Posted by Michael Wonder on 27 Sep 2018
Protagonist Therapeutics announces fast track designation granted by U.S. FDA to hepcidin mimetic PTG-300
27 September 2018 - Designation applies to development for the treatment of chronic anemia in patients with beta-thalassemia. ...
Posted by Michael Wonder on 27 Sep 2018
Aronora's new blood clot treatment receives FDA fast track designation
26 September 2018 - Enzyme that selectively targets blood clots has received FDA fast track designation, allowing for expedited clinical development. ...