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RSS FeedPosted by Michael Wonder on 07 Aug 2018
Nohla Therapeutics receives FDA fast track designation for dilanubicel for allogeneic cord blood transplant patients
6 August 2018 - Nohla Therapeutics today announced that the U.S. FDA has granted fast track designation to dilanubicel (NLA101) for ...
Posted by Michael Wonder on 06 Aug 2018
U.S. FDA grants fast track designation for BioCryst’s BCX7353
6 August 2018 - BioCryst Pharmaceuticals today announced that the Company has been granted fast track designation by the U.S. ...
Posted by Michael Wonder on 31 Jul 2018
Soleno Therapeutics receives fast track designation from FDA for DCCR for treatment of Prader-Willi syndrome
30 July 2018 - Phase III clinical trial ongoing at multiple sites in the U.S. ...
Posted by Michael Wonder on 29 Jul 2018
Ultragenyx announces first patient dosed in Phase 1/2 study of DTX401, a gene therapy for the treatment of glycogen storage disease Type Ia; FDA grants fast track designation to gene therapy program
26 July 2018 - Ultragenyx today announced that the first patient has been dosed in the Phase 1/2 study of DTX401, ...
Posted by Michael Wonder on 26 Jul 2018
Assembly Biosciences announces FDA fast track designation granted to ABI-H0731 for the treatment of hepatitis B virus infection
25 July 2018 - Assembly Biosciences today announced that the U.S. FDA has granted fast track designation to ABI-H0731 for the ...
Posted by Michael Wonder on 24 Jul 2018
Apellis Pharmaceuticals’ APL-2 receives fast track designation from FDA for the treatment of patients with geographic atrophy
24 July 2018 - Apellis Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 23 Jul 2018
Allergan receives FDA fast track designation for AGN-241751 for the treatment of major depressive disorder
23 July 2018 - Phase 2 clinical study underway. ...
Posted by Michael Wonder on 23 Jul 2018
BeiGene announces plan to pursue accelerated approval in the U.S. of BTK inhibitor zanubrutinib in Waldenström macroglobulinaemia
22 July 2018 - Fast track designation granted by U.S. FDA. ...
Posted by Michael Wonder on 20 Jul 2018
Sellas receives fast track designation from FDA for galinpepimut-S for the treatment of patients with multiple myeloma
20 July 2018 - Sellas Life Sciences today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 16 Jul 2018
Tonix Pharmaceuticals receives fast track designation from the U.S. FDA for TNX-102 SL for treatment of agitation in Alzheimer’s disease
16 July 2018 - Tonix Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its investigational new ...
Posted by Michael Wonder on 10 Jul 2018
FDA grants fast track designation to Aclaris Therapeutics’ investigational JAK inhibitor for the treatment of alopecia areata
9 July 2018 - Aclaris Therapeutics announced today that the U.S. FDA has granted fast track designation to Aclaris’ investigational topical ...
Posted by Michael Wonder on 02 Jul 2018
Fortress Biotech announces Cyprium Therapeutics’ CUTX-101 (copper histidinate) granted FDA fast track designation for treatment of classic Menkes disease
2 July 2018 - Fortress Biotech today announced that the U.S. FDA has granted fast track designation to Cyprium Therapeutics’ (“Cyprium”) ...
Posted by Michael Wonder on 18 Jun 2018
ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer
18 June 2018 - ImmunoGen today announced that the U.S. FDA has granted fast track designation for its lead program, ...
Posted by Michael Wonder on 13 Jun 2018
Nordic Nanovector announces Betalutin has been granted fast track designation in the US for follicular lymphoma
12 June 2018 - Nordic Nanovector announces that the US FDA has granted fast track designation to Betalutin (177Lu-lilotomab satetraxetan) ...
Posted by Michael Wonder on 13 Jun 2018
RegenxBio receives FDA fast track designation for RGX-111 gene therapy for the treatment of mucopolysaccharidosis type I
12 June 2018 - Phase I clinical trial expected to enroll children and adults with MPS I. ...