Blog
RSS FeedPosted by Michael Wonder on 04 Jan 2021
FDA grants ARX788 fast track designation for HER2 positive metastatic breast cancer
4 January 2021 - Ambrx announced that the U.S. FDA granted ARX788 fast track designation as monotherapy for the treatment of ...
Posted by Michael Wonder on 18 Dec 2020
Novaremed receives fast track designation from the FDA for NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy
18 December 2020 - Novaremed announced today that it has received fast track designation from the U.S. FDA for the development ...
Posted by Michael Wonder on 17 Dec 2020
Decibel Therapeutics announces DB-020 has been granted fast track designation by the U.S. FDA
17 December 2020 - Decibel Therapeutics today announced that their clinical product candidate, DB-020, has been granted fast track designation ...
Posted by Michael Wonder on 16 Dec 2020
Durect Corporation announces DUR-928 granted FDA fast track designation for treatment of alcoholic hepatitis
16 December 2020 - Durect Corporation today announced that the U.S. FDA has granted fast track designation to DUR-928 for ...
Posted by Michael Wonder on 15 Dec 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of acute myeloid leukaemia
15 December 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 14 Dec 2020
Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Dec 2020
Gannex received U.S. FDA fast track designation for its NASH drug candidate ASC42, an FXR agonist
13 December 2020 - Gannex announced today that it received fast track designation from the U.S. FDA for its non-alcoholic steatohepatitis ...
Posted by Michael Wonder on 12 Dec 2020
Lexicon Pharmaceuticals receives fast track designation from the FDA for LX9211 for diabetic peripheral neuropathic pain
11 December 2020 - Lexicon Pharmaceuticals announced today that it has received Fast Track designation from the U.S. FDA for ...
Posted by Michael Wonder on 07 Dec 2020
Immunicum receives FDA fast track designation for ilixadencel in gastro-intestinal stromal tumours
7 December 2020 - Immunicum announced today that it has received fast track designation from the U.S. FDA for the Company’s ...
Posted by Michael Wonder on 04 Dec 2020
enGene receives fast track designation for EG-70 for the treatment of non-muscle invasive bladder cancer
3 December 2020 - enGene announced today that the U.S. FDA has granted fast track designation to enGene for EG-70, the ...
Posted by Michael Wonder on 03 Dec 2020
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in haemophilia A or B with inhibitors
2 December 2020 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for marzeptacog alfa (activated) – ...
Posted by Michael Wonder on 03 Dec 2020
Protagonist's hepcidin mimetic candidate PTG-300 receives fast track designation from the U.S. FDA for development in the treatment of polycythemia vera
2 December 2020 - Protagonist Therapeutics today announced that the U.S. FDA has granted fast track designation to PTG-300 in the ...
Posted by Michael Wonder on 03 Dec 2020
FDA grant fast track designation for remestemcel-L in the treatment of acute respiratory distress syndrome due to COVID-19
2 December 2020 - Mesoblast today announced that the United States FDA has granted fast track designation for remestemcel-L in the ...
Posted by Michael Wonder on 01 Dec 2020
Ipsen receives FDA fast track designation for investigational irinotecan liposome injection (Onivyde) as a second-line monotherapy treatment for small cell lung cancer
30 November 2020 - Ipsen today announced the United States FDA has granted the company fast track designation for irinotecan liposome ...
Posted by Michael Wonder on 01 Dec 2020
Karolinska Development's portfolio company Aprea Therapeutics receives FDA fast track designation for eprenetapopt in AML
30 November 2020 - Karolinska Development announces today that the U.S. FDA has granted fast track designation for eprenetapopt in the ...