Blog
RSS FeedPosted by Michael Wonder on 01 Jun 2018
Curis announces FDA fast track designation for fimepinostat (CUDC-907) development in patients with relapsed or refractory diffuse large B-cell lymphoma
31 May 2018 - Curis announced today that the U.S. FDA has granted fast track designation for the development of fimepinostat ...
Posted by Michael Wonder on 30 May 2018
TrioxBio announces fast track designation granted by U.S. FDA to Raviten for the treatment of intradialytic hypotension
29 May 2018 - Phase II clinical trials in patients undergoing hemodialysis to be initiated in Q4, 2018. ...
Posted by Michael Wonder on 25 May 2018
U.S. FDA grants fast track designation for Krystal Biotech’s KB103 for the treatment of dystrophic epidermolysis bullosa
24 May 2018 - Krystal Biotech today announces that the U.S. FDA has granted fast track designation to KB103 for ...
Posted by Michael Wonder on 22 May 2018
Harmony Biosciences receives breakthrough therapy and fast track designations for pitolisant
21 May 2018 - Expanded access program for pitolisant is open and patients are being enrolled. ...
Posted by Michael Wonder on 15 May 2018
FDA grants fast track designation for Yamo Pharmaceutical’s L1-79 in autism spectrum disorder
14 May 2018 - Yamo Pharmaceuticals announced today that the US FDA has granted fast track designation for its investigational ...
Posted by Michael Wonder on 09 May 2018
Forty Seven granted fast track designation for 5F9 for the treatment of diffuse large B-cell lymphoma and follicular lymphoma
3 May 2018 - Forty Seven today announced that the U.S. FDA has granted two fast track designations to its lead ...
Posted by Michael Wonder on 09 May 2018
FDA grants fast track designation to Debiopharm's Debio 1347 for the treatment of patients with unresectable or metastatic tumours with a specific FGFR gene alteration
8 May 2018 - Debiopharm announced today that the U.S. FDA has granted fast track designation to Debio 1347, an ...
Posted by Michael Wonder on 05 May 2018
FDA grants PaxVax fast track designation for its Chikungunya vaccine
4 May 2018 - There are no licensed vaccines for chikungunya prevention and no specific treatments. ...
Posted by Michael Wonder on 03 May 2018
RegenxBio receives FDA fast track designation for RGX-121 gene therapy for the treatment of mucopolysaccharidosis Type II
2 May 2018 - Phase I/II clinical trial expected to enrol children with MPS II. ...
Posted by Michael Wonder on 01 May 2018
Acceleron receives FDA fast track designation for ACE-083 in facioscapulohumeral muscular dystrophy
1 May 2018 - Acceleron Pharma today announced that the U.S. FDA has granted fast track designation to ACE-083, a ...
Posted by Michael Wonder on 01 May 2018
Scynexis' oral SCY-078 receives FDA QIDP and fast track designations for the treatment of VVC and prevention of recurrent VVC
1 May 2018 - Enrollment completed in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018. ...
Posted by Michael Wonder on 26 Apr 2018
FDA grants fast track designation for OrphoMed’s ORP-101 for treatment of IBS-D
25 April 2018 - OrphoMed announced today that the U.S. FDA has granted fast track designation for the Company’s lead ...
Posted by Michael Wonder on 26 Apr 2018
Synlogic receives fast track designation for SYNB1618, a synthetic biotic medicine for the treatment of phenylketonuria
25 April 2018 - Phase 1/2a clinical study of SYNB1618 evaluating safety and tolerability as well as exploratory endpoints expected ...
Posted by Michael Wonder on 26 Apr 2018
Enzychem Lifesciences' fast track designation for chemo-radiation induced oral mucositis had been granted by the FDA
24 April 2018 - On 14 March, the U.S. FDA has granted Enzychem Lifesciences fast track designation of clinical study of ...
Posted by Michael Wonder on 23 Apr 2018
MeiraGTx announces AAV-RPGR granted fast track designation by U.S. FDA for treatment of X-linked retinitis pigmentosa due to RPGR deficiency
23 April 2018 - MeiraGTx Limited today announced that the U.S. FDA has granted fast track designation for AAV-RPGR for the ...