Blog
RSS FeedPosted by Michael Wonder on 02 Feb 2018
Protalix BioTherapeutics’ pegunigalsidase alfa receives fast track designation from the U.S. FDA
31 January 2018 - Fast Track designation highlights high unmet medical need in the treatment of Fabry disease. ...
Posted by Michael Wonder on 30 Jan 2018
Takeda's Zika vaccine gets U.S. FDA's 'fast track' status
30 January 2018 - Japan’s Takeda Pharmaceutical Co Ltd said on Monday the U.S. FDA had granted ‘fast track’ status to ...
Posted by Michael Wonder on 28 Jan 2018
Synthon’s [vic-]trastuzumab duocarmazine (SYD985) granted FDA fast track designation for pre-treated HER2-positive metastatic breast cancer
25 January 2018 - Synthon Biopharmaceuticals today announced that the U.S. FDA has granted fast track designation for its investigational ...
Posted by Michael Wonder on 23 Jan 2018
FDA accepts investigational new drug application and grants fast track status for SOBI003 for the treatment of MPS IIIA
23 January 2018 - Swedish Orphan Biovitrum announces that the FDA has issued a study may proceed letter for the ...
Posted by Michael Wonder on 18 Jan 2018
Lyric Pharma granted FDA fast track designation for lead product ulimorelen for enteral feeding intolerance
17 January 2018 - Lyric Pharmaceuticals today announced that the United States FDA has granted fast track designation to the investigation ...
Posted by Michael Wonder on 18 Jan 2018
Aspyrian Therapeutics announces successful advances in RM-1929 clinical development in recurrent head and neck cancer, including fast track designation granted by the FDA
16 January 2018 - Aspyrian plans to initiate pivotal clinical trials for RM-1929 in the first quarter of 2018. ...
Posted by Michael Wonder on 16 Jan 2018
Centrexion Therapeutics announces fast track designation granted by FDA to CNTX-4975 for treatment of knee osteoarthritis pain
16 January 2018 - Centrexion Therapeutics today announced that the U.S. FDA has granted fast track designation to CNTX-4975 for ...
Posted by Michael Wonder on 13 Jan 2018
Cour Pharmaceuticals receives FDA fast track designation for TIMP-GLIA
8 January 2018 - TIMP-GLIA is designed to enable patients to develop tolerance to gluten. ...
Posted by Michael Wonder on 13 Jan 2018
FDA grants fast track designation to Concert Pharmaceuticals' CTP-543 for the treatment of alopecia areata
12 January 2018 - CTP-543 is a novel JAK inhibitor in Phase 2 for alopecia areata as potential first-in-class treatment. ...
Posted by Michael Wonder on 04 Jan 2018
VistaGen Therapeutics receives FDA fast track designation for AV-101 for the treatment of major depressive disorder
3 January 2018 - VistaGen Therapeutics announced today that the U.S. FDA has granted fast track designation to AV-101 for ...
Posted by Michael Wonder on 27 Dec 2017
DelMar Pharmaceuticals announces fast track designation for VAL-083 in recurrent glioblastoma
26 December 2017 - Supports lead program, VAL-083, in on-going clinical trials. ...
Posted by Michael Wonder on 27 Dec 2017
FDA grants Insys Therapeutics ‘fast track’ designation for cannabidiol oral solution as investigational treatment for Prader-Willi syndrome
26 December 2017 - INSYS Therapeutics announced today that the U.S. FDA has granted fast track designation to the company’s cannabidiol ...
Posted by Michael Wonder on 19 Dec 2017
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Angelman syndrome
19 December 2017 - Ovid Therapeutics today announced that the U.S. FDA has granted fast track designation to OV101 for the ...
Posted by Michael Wonder on 19 Dec 2017
Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of Leber’s hereditary optic neuropathy
18 December 2017 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead candidate, ...
Posted by Michael Wonder on 17 Dec 2017
WTX101 granted fast track designation by the U.S. FDA for the treatment of Wilson disease
14 December 2017 - Wilson Therapeutics today announced that the U.S. FDA has granted WTX101 fast track designation for the treatment ...