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RSS FeedPosted by Michael Wonder on 11 Mar 2021
FDA grants fast track designation to Spectrum Pharmaceuticals’ poziotinib
11 March 2021 - Spectrum Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for poziotinib for the ...
Posted by Michael Wonder on 10 Mar 2021
Vertex announces FDA fast track designation and initiation of a Phase 1/2 clinical trial for VX-880, a novel investigational cell therapy for the treatment of type 1 diabetes
10 March 2021 - VX-880 is the first investigational stem cell derived therapy utilising fully differentiated, insulin-producing pancreatic islet cells for ...
Posted by Michael Wonder on 09 Mar 2021
AltruBio’s neihulizumab granted fast track designation by the FDA for steroid refractory acute graft versus host disease
8 March 2021 - AltruBio announced today that the U.S. FDA granted fast track designation for its immune checkpoint regulator, ...
Posted by Michael Wonder on 08 Mar 2021
U.S. FDA grants fast track designation to three Passage Bio gene therapy candidates targeting rare CNS disorders
8 March 2021 - FDA designation will facilitate development and expedited review of company’s lead gene therapy product candidates for ...
Posted by Michael Wonder on 03 Mar 2021
Oblato announces fast track designation of OKN-007 for diffuse intrinsic pontine glioma from the FDA
3 March 2021 - Oblato announces that the FDA granted fast track designation of OKN-007, the proprietary drug for diffuse intrinsic ...
Posted by Michael Wonder on 22 Feb 2021
Celsion Corporation receives FDA fast track designation for GEN-1 in advanced ovarian cancer
22 February 2021 - Designation provides potential for an expedited regulatory review.. ...
Posted by Michael Wonder on 19 Feb 2021
Efanesoctocog alfa granted FDA fast track designation for treatment of haemophilia A
18 February 2021 - Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential ...
Posted by Michael Wonder on 15 Feb 2021
Targovax receives fast track designation for ONCOS-102
15 February 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in malignant ...
Posted by Michael Wonder on 08 Feb 2021
Ellodi Pharmaceuticals announces fast track designation granted by the FDA to APT-1011 for the treatment of eosinophilic osophagitis
8 February 2021 - Ellodi Pharmaceuticals today announced that APT-1011 (fluticasone propionate oral disintegrating tablet) has been granted fast track designation ...
Posted by Michael Wonder on 04 Feb 2021
Theratechnologies’ lead peptide drug conjugate TH1902 receives FDA fast track designation for the treatment of sortilin-expressing cancers
4 February 2021 - Theratechnologies is pleased to announce that the United States FDA has granted fast track designation to TH1902 ...
Posted by Michael Wonder on 03 Feb 2021
Asana BioSciences’ gusacitinib granted FDA fast track designation for moderate to severe chronic hand eczema
4 February 2021 - Asana BioSciences announced today that the U.S. FDA has granted fast track designation to Asana’s gusacitinib (ASN002), ...
Posted by Michael Wonder on 03 Feb 2021
Cerecor announces fast track designation for CERC-803 for the treatment of leukocyte adhesion deficiency type II
2 February 2021 - Cerecor today announced that the U.S. FDA has granted fast track designation to CERC-803 for the treatment ...
Posted by Michael Wonder on 30 Jan 2021
Phase 1 drug candidate GLR2007 developed by Gan & Lee has been granted fast track designation by the U.S. FDA
29 January 2021 - Gan & Lee Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for GLR2007, ...
Posted by Michael Wonder on 26 Jan 2021
MeiraGTx announces AAV-CNGA3 granted fast track designation by U.S. FDA for treatment of achromatopsia
26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy ...
Posted by Michael Wonder on 25 Jan 2021
FDA grants toripalimab fast track designation for mucosal melanoma
25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...