Blog
RSS FeedPosted by Michael Wonder on 31 Jan 2019
Innate Pharma receives FDA fast track designation for IPH4102 in relapsed or refractory Sézary syndrome
29 January 2019 - Fast track designation is based on the evaluation of Phase I results demonstrating strong clinical activity, favourable ...
Posted by Michael Wonder on 17 Jan 2019
Acurx receives FDA fast track designation for ACX-362E for the treatment of C. difficile infection
16 January 2019 - Phase 1 clinical study underway - anticipated completion second quarter 2019. ...
Posted by Michael Wonder on 09 Jan 2019
OncoNano receives authorisation to proceed from FDA for IND application and fast track designation for ONM-100, intra-operative imaging agent to detect tumours and metastatic lymph nodes that often go undetected during surgery
4 January 2019 - FDA says proposed Phase 2 clinical trial may proceed. ...
Posted by Michael Wonder on 09 Jan 2019
RadioMedix and Curium announce FDA fast track designation for 64Cu dotatate
9 January 2019 - RadioMedix and its commercial partner Curium announced today that their investigational diagnostic radiopharmaceutical, 64Cu dotatate, was granted ...
Posted by Michael Wonder on 07 Jan 2019
FDA grants Revalesio fast track status for ALS investigational drug RNS60
4 January 2019 - Revalesio announced today that the U.S. FDA granted fast track status for its investigational drug RNS60 as ...
Posted by Michael Wonder on 07 Jan 2019
Rainier Therapeutics announces fast track designation granted by FDA for vofatamab in treatment of FGFR3-positive urothelial cell carcinoma
7 January 2019 - Rainier Therapeutics today announced that its targeted antibody vofatamab has received fast track designation from the U.S. ...
Posted by Michael Wonder on 06 Jan 2019
CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of sickle cell disease
4 January 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for ...
Posted by Michael Wonder on 03 Jan 2019
ImmusanT secures fast track designation for lead therapeutic vaccine candidate Nexvax2 for patients with celiac disease
2 January 2019 - Nexvax2 has been designed to potentially restore immune tolerance to gluten in patients with celiac disease. ...
Posted by Michael Wonder on 02 Jan 2019
ProQR receives fast track designation from FDA for QR-421a for Usher Syndrome Type 2
2 January 2019 - ProQR Therapeutics today announced that it received fast track designation from the FDA for QR-421a. ...
Posted by Michael Wonder on 27 Dec 2018
BioXcel Therapeutics receives FDA fast track designation for BXCL501 for acute treatment of agitation
27 December 2018 - Fast track designation for BXCL501 will help facilitate anticipated registration trials in 2019 upon completion of pharmacokinetic ...
Posted by Michael Wonder on 25 Dec 2018
Valneva awarded FDA fast track designation for Chikungunya vaccine candidate
21 December 2018 - Valneva announced today that the U.S. FDA has granted fast track designation for its chikungunya vaccine candidate, ...
Posted by Michael Wonder on 23 Dec 2018
Gritstone Oncology announces FDA fast track designation for GRANITE-001 for the treatment of colorectal cancer
20 December 2018 - Gritstone Oncology today announced that the U.S. FDA has granted fast track designation to GRANITE-001 for the ...
Posted by Michael Wonder on 19 Dec 2018
Equillium granted U.S. FDA fast track designation for EQ001 for the treatment of acute graft-versus-host disease
19 December 2018 - Company plans to initiate Phase 1b/2 EQUATE clinical trial in early 2019. ...
Posted by Michael Wonder on 13 Dec 2018
FDA grants fast track designation to the baricitinib development program for the treatment of systemic lupus erythematosus
13 December 2018 - Eli Lilly and Incyte announced today that the U.S. FDA has granted fast track designation to ...
Posted by Michael Wonder on 11 Dec 2018
Non-cystic fibrosis bronchiectasis FDA grants “fast-track” and “QIPD” to Zambon for colistimethate sodium powder for nebuliser solution delivered by the I-neb AAD system
11 December 2018 - Non–cystic fibrosis bronchiectasis is a, chronic, progressive and irreversible disease, prevalent in Europe and the US. ...