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RSS FeedPosted by Michael Wonder on 21 Mar 2019
Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations
21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...
Posted by Michael Wonder on 14 Mar 2019
FDA grants Purdue Pharma’s nalmefene hydrochloride injection fast track designation for the emergency treatment of known or suspected opioid overdose
13 March 2019 - Committed to advancing solutions to the opioid public health crisis, Purdue will not profit from nalmefene hydrochloride. ...
Posted by Michael Wonder on 27 Feb 2019
Iovance Biotherapeutics was granted fast track designation for LN-145 for cervical cancer
26 February 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted fast track designation for LN-145 for the ...
Posted by Michael Wonder on 26 Feb 2019
Themis Bioscience receives FDA fast track designation for Chikungunya vaccine candidate
25 February 2019 - Themis Bioscience announced today that the United States FDA has granted fast track designation to the ...
Posted by Michael Wonder on 21 Feb 2019
Cerecor receives fast track designation from FDA for CERC-801 for the treatment of PGM1 deficiency
19 February 2019 - Cerecor announced today that the U.S. FDA has designated fast track designation for CERC-801, an ultra-pure, oral ...
Posted by Michael Wonder on 21 Feb 2019
Neurelis announces that Intravail licensee ARS Pharmaceuticals intranasal epinephrine program given fast track designation
20 February 2019 - ARS Pharmaceuticals announced that ARS-1, an intranasal epinephrine spray in development to treat severe allergic reactions, was ...
Posted by Michael Wonder on 16 Feb 2019
OncoGenex announces fast track designation granted for custirsen in combination with cabazitaxel/prednisone as second-line chemotherapy in Phase 3 AFFINITY trial of men with metastatic castrate-resistant prostate cancer
23 April 2014 - Third Phase 3 trial of custirsen to receive FDA fast track designation. ...
Posted by Michael Wonder on 16 Feb 2019
Tokai Pharmaceuticals’ galeterone receives fast track designation from the FDA for the treatment of advanced prostate cancer
12 June 2012 - Tokai Pharmaceuticals today announced that its lead candidate, galeterone (TOK-001), has received fast track designation from ...
Posted by Michael Wonder on 16 Feb 2019
Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint
24 October 2018 - Bayer has been granted fast track designation by the U.S. FDA for darolutamide in men with nmCRPC. ...
Posted by Michael Wonder on 16 Feb 2019
Innocrin Pharmaceuticals granted fast track designation by FDA for VT-464 treatment of patients with metastatic castrate-resistant prostate cancer
6 January 2016 - Seviteronel to be presented in three sessions at the ASCO Genitourinary Cancer Symposium to be held in ...
Posted by Michael Wonder on 15 Feb 2019
RDD Pharma receives fast track designation from FDA for RDD-0315 for treatment of faecal incontinence in spinal cord injury patients
14 February 2019 - RDD Pharma announced today that the U.S. FDA granted fast track status for RDD-0315 for the treatment ...
Posted by Michael Wonder on 13 Feb 2019
Neurotech Pharmaceuticals granted fast track designation from the U.S. FDA for the treatment of macular telangiectasia type 2
12 February 2019 - Neurotech Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company's development ...
Posted by Michael Wonder on 11 Feb 2019
Apellis Pharmaceuticals’ APL-2 receives fast track designation from the FDA for the treatment of patients with paroxysmal nocturnal haemoglobinuria
11 February 2019 - New designation now includes all PNH patients. ...
Posted by Michael Wonder on 05 Feb 2019
Pharnext announces FDA fast track designation for Pleodrug PXT3003 for the treatment of Charcot-Marie-Tooth disease type 1A
4 February 2019 - Pharnext announced today that the U.S. FDA has granted fast track designation for the development of PXT3003 ...
Posted 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 ...