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RSS FeedPosted by Michael Wonder on 04 Nov 2020
LogicBio Therapeutics receives FDA fast track designation for LB-001 for the treatment of methylmalonic acidemia
4 November 2020 - LogicBio Therapeutics announced today the U.S. FDA has granted fast track designation to its clinical candidate, LB-001 ...
Posted by Michael Wonder on 28 Oct 2020
Astellas receives U.S. FDA fast track designation for ASP5354, an investigational near-infrared fluorescence imaging agent
28 October 2020 - Astellas Pharma announced today that the US FDA has granted fast track designation based on non-clinical and ...
Posted by Michael Wonder on 27 Oct 2020
Dracen Pharmaceutical’s DRP-104 granted U.S. FDA fast track designation for the treatment of non-small cell lung cancer
27 October 2020 - Dracen to work closely with FDA to advance the clinical program for the treatment of non-small cell ...
Posted by Michael Wonder on 27 Oct 2020
Prevail Therapeutics receives U.S. FDA fast track designation for PR001 for the treatment of neuronopathic Gaucher disease
27 October 2020 - Prevail Therapeutics today announced that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 26 Oct 2020
Forte Biosciences announces the FDA has granted fast track designation to FB-401 for the treatment of atopic dermatitis
26 October 2020 - Forte Biosciences today announced that the U.S. FDA has granted fast track designation to FB-401 for the ...
Posted by Michael Wonder on 21 Oct 2020
U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARδ modulator being developed for the treatment of primary mitochondrial myopathies
20 October 2020 - Astellas Pharma today announced that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 21 Oct 2020
TG Therapeutics announces fast track designation granted by the FDA to ublituximab in combination with umbralisib for the treatment of adult patients with chronic lymphocytic leukaemia
21 October 2020 - TG Therapeutics today announced that the U.S. FDA has granted fast track designation to the combination of ...
Posted by Michael Wonder on 21 Oct 2020
Xeris Pharmaceuticals granted fast track designation by the FDA for its novel concentrated diazepam formulation (XP-0863) for injection
20 October 2020 - Xeris Pharmaceuticals today announced it was granted fast track designation by the FDA for the investigation ...
Posted by Michael Wonder on 19 Oct 2020
Inventiva receives FDA fast track designation in MPS VI for its clinical-stage asset odiparcil
19 October 2020 - Inventiva today announced that the U.S. FDA has granted fast track designation to odiparcil, the Company’s clinical-stage ...
Posted by Michael Wonder on 13 Oct 2020
PMV Pharma granted FDA fast track designation of PC14586 for the treatment of advanced cancer patients that have tumours with a p53 Y220C mutation
13 October 2020 - PMV Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its lead product ...
Posted by Michael Wonder on 09 Oct 2020
X4 Pharmaceuticals announces fast track designation granted by the FDA to mavorixafor for the treatment of WHIM syndrome
8 October 2020 - X4 Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 04 Oct 2020
BioMarin receives FDA fast track designation for investigational gene therapy, BMN 307
2 October 2020 - Second investigational gene therapy in clinic, potential third therapy in PKU franchise. ...
Posted by Michael Wonder on 02 Oct 2020
FDA grants fast track designation to Calibr’s ‘switchable’ CAR-T cell cancer therapy, CLBR001 + SWI019
1 October 2020 - Phase 1 clinical trial is now enrolling patients with blood cancers. ...
Posted by Michael Wonder on 02 Oct 2020
Pfizer receives FDA fast track designation for Duchenne muscular dystrophy investigational gene therapy
1 October 2020 - Pfizer today announced that its investigational gene therapy candidate (PF-06939926) being developed to treat Duchenne muscular dystrophy ...
Posted by Michael Wonder on 02 Oct 2020
FDA grants fast track status to Aegle Therapeutics' AGLE-102 for the treatment of dystrophic epidermolysis bullosa
1 October 2020 - Aegle Therapeutics Corporation today announced the U.S. FDA has granted fast track designation to AGLE-102 for ...