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RSS FeedPosted by Michael Wonder on 26 Dec 2021
Investigational Alzheimer’s disease therapy lecanemab granted FDA fast track designation
23 December 2021 - Eisai and Biogen announced today that lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of ...
Posted by Michael Wonder on 19 Dec 2021
Xalud Therapeutics receives FDA fast track designation for XT-150 for the treatment of pain associated with osteoarthritis of the knee
17 December 2021 - Xalud Therapeutics announced today that the United States FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 15 Dec 2021
Sapience Therapeutics receives FDA fast track designation for ST101 for advanced cutaneous melanoma
15 December 2021 - Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 15 Dec 2021
Nuvation Bio receives FDA fast track designation for NUV-422 for the treatment of high grade gliomas, including glioblastoma multiforme
15 December 2021 - Nuvation Bio today announced that the U.S. FDA has granted fast track designation to NUV-422, a cyclin-dependent ...
Posted by Michael Wonder on 06 Dec 2021
Sapience Therapeutics receives FDA fast track designation for ST101 for the treatment of recurrent glioblastoma multiforme
6 December 2021 - Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 01 Dec 2021
U.S. FDA grants Bionomics fast track designation to BNC210 for the acute treatment of social anxiety disorder and other anxiety related disorders
1 December 2021 - Bionomics is pleased to announce that the U.S. FDA has granted fast track designation to the ...
Posted by Michael Wonder on 30 Nov 2021
Hepion Pharmaceuticals receives FDA fast track designation for CRV431 for the treatment of NASH
30 November 2021 - Hepion Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for the Company’s lead ...
Posted by Michael Wonder on 23 Nov 2021
Isofol Medical receives FDA fast track designation for arfolitixorin in advanced colorectal cancer
23 November 2021 - Isofol Medical announced today that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 23 Nov 2021
Prilenia receives fast track designation for pridopidine for the treatment of Huntington’s disease
17 November 2021 - Prilenia Therapeutics today announced that the U.S. FDA has granted Fast Track designation to pridopidine for ...
Posted by Michael Wonder on 20 Nov 2021
BioNTech receives FDA fast track designation for its FixVac candidate BNT111 in advanced melanoma
19 November 2021 - BioNTech today announced that the U.S. FDA granted fast track designation for BNT111, an investigational cancer ...
Posted by Michael Wonder on 20 Nov 2021
Reata Pharmaceuticals receives fast track designation from the FDA for omaveloxolone for the treatment of Friedreich’s ataxia
18 November 2021 - Reata Pharmaceuticals today announced the U.S. FDA has granted fast track designation for omaveloxolone for the ...
Posted by Michael Wonder on 17 Nov 2021
Zentalis Pharmaceuticals announces fast track designation granted by the U.S. FDA to ZN-c3 for the treatment of uterine serous carcinoma
17 November 2021 - Zentalis Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to ZN-c3, the Company’s ...
Posted by Michael Wonder on 17 Nov 2021
Lokelma granted fast track designation in the US to reduce cardiovascular outcomes in patients on chronic haemodialysis with hyperkalaemia
17 November 2021 - AstraZeneca has been granted fast track designation in the United States for the development of Lokelma (sodium ...
Posted by Michael Wonder on 09 Nov 2021
BerGenBio receives FDA fast track designation for bemcentinib in STK11 mutated advanced/metastatic non-small-cell lung cancer
9 November 2021 - BerGenBio today announces that the U.S. FDA has granted fast track designation for bemcentinib in combination with ...
Posted by Michael Wonder on 09 Nov 2021
Plus Therapeutics receives FDA fast track designation for 186RNL targeted radiotherapeutic for leptomeningeal metastases
9 November 2021 - Plus Therapeutics today announced that the U.S. FDA has granted the Company fast track designation for ...