Blog
RSS FeedPosted by Michael Wonder on 17 Dec 2017
US FDA grants fast track designation to Renova Therapeutics’ RT-100 AC6 gene transfer for the treatment of heart failure
14 December 2107 - FLOURISH Phase 3 clinical trial in patients with heart failure and reduced ejection fraction to begin ...
Posted by Michael Wonder on 11 Dec 2017
BioVie receives FDA fast track designation for BIV201 for the treatment of refractory ascites due to advanced liver cirrhosis
11 December 2017 - BioVie announced today that the US FDA has granted fast track designation for BIV201 (continuous infusion terlipressin), ...
Posted by Michael Wonder on 11 Dec 2017
Rhizen Pharmaceuticals S.A. receives FDA fast track designation for RP6530 (tenalisib), a highly selective dual PI3K delta/gamma inhibitor for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma
9 December 2017 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for RP6530 (tenalisib), the ...
Posted by Michael Wonder on 08 Dec 2017
Aptinyx granted fast track designation, initiates Phase 1 for second clinical candidate, NYX-783, in post-traumatic stress disorder
7 December 2017 - Data presented at American College of Neuropsychopharmacology Annual Meeting demonstrate robust and durable response in models relevant ...
Posted by Michael Wonder on 08 Dec 2017
Concentric Analgesics receives FDA fast track designation for CA-008 for post-surgical pain
7 December 2017 - Novel pro-drug with unique mechanism of action takes on the opioid crisis. ...
Posted by Michael Wonder on 03 Dec 2017
ArmaGen’s AGT-181 granted fast track designation for the treatment of Hurler syndrome
30 November 2017 - ArmaGen today reported that the U.S. FDA has granted fast track designation to AGT-181, a novel, ...
Posted by Michael Wonder on 02 Dec 2017
Arog Pharmaceuticals receives FDA fast track designation for crenolanib in relapsed or refractory FLT3-positive AML
1 December 2017 - Arog Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for crenolanib for ...
Posted by Michael Wonder on 29 Nov 2017
U.S. FDA grants fast track designation for Idera Pharmaceuticals’ IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma
29 November 2017 - Phase 3 trial initiation planned for first quarter 2018. ...
Posted by Michael Wonder on 28 Nov 2017
Stealth BioTherapeutics granted fast track designation for the treatment of Barth syndrome
27 November 2017 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead ...
Posted by Michael Wonder on 20 Nov 2017
Intra-Cellular Therapies receives FDA fast track designation for lumateperone for the treatment of schizophrenia
20 November 2017 - Intra-Cellular Therapies today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation ...
Posted by Michael Wonder on 02 Nov 2017
FDA grants fast track designation to Visterra’s VIS410 for treatment of hospitalised patients with influenza A
1 November 2017 - Company plans to initiate Phase 2b clinical trial in early 2018. ...
Posted by Michael Wonder on 01 Nov 2017
Geron announces fast track designation granted to imetelstat for lower risk myelodysplastic syndromes
31 October 2017 - Expanded part 1 of IMerge is open for patient enrolment. ...
Posted by Michael Wonder on 01 Nov 2017
Citius Pharmaceuticals receives fast track designation by FDA For Mino-Lok investigational trial
31 October 2017 - Citius Pharmaceuticals announced today it has received official notice from the U. S. FDA that the investigational ...
Posted by Michael Wonder on 29 Oct 2017
Heron Therapeutics granted FDA fast track designation for HTX-011 to reduce post-operative pain and the need for opioid analgesics for 72 hours
26 October 2017 - Phase 3 studies for HTX-011 ongoing; NDA filing planned for 2018. ...
Posted by Michael Wonder on 27 Oct 2017
Prometic receives fast track designation for PBI-4050 in development for idiopathic pulmonary fibrosis
25 October 2017 - Fast track designation follows recent FDA approval of pivotal Phase 2/3 clinical trial in IPF. ...