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RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Nov 2020
RhoVac's prostate cancer drug candidate RV001 is granted fast track designation by the FDA
25 November 2020 - RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to ...
Posted by Michael Wonder on 23 Nov 2020
Theralase granted FDA fast track designation for NMIBC Phase 2 clinical study
23 November 2020 - Theralase Technologies announced today that the U.S. FDA has granted Theralase fast track designation for its ...
Posted by Michael Wonder on 23 Nov 2020
AB201 development as a potential treatment for COVID-19 receives U.S. FDA fast track designation
23 November 2020 - AB201 is the only novel compound being developed for COVID associated coagulopathy. ...
Posted by Michael Wonder on 20 Nov 2020
PTC Therapeutics announces key regulatory designations for PTC596 to advance treatment of two rare oncology indications
18 November 2020 - PTC Therapeutics today announced that the United States FDA has granted PTC596 both orphan drug designation and ...
Posted by Michael Wonder on 20 Nov 2020
Lumicell granted fast track designation approval by the FDA for breast cancer treatment
18 November 2020 - Fast track designation augments previously granted breakthrough device designation. ...
Posted by Michael Wonder on 18 Nov 2020
Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia
18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment ...
Posted by Michael Wonder on 11 Nov 2020
Surface Oncology announces FDA fast track designation granted by U.S. Food and Drug Administration for SRF388 to treat liver cancer
11 November 2020 - Surface Oncology today announced that the U.S. FDA has granted fast track designation to SRF388 for ...
Posted by Michael Wonder on 10 Nov 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of pancreatic cancer
10 November 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 09 Nov 2020
Novavax COVID-19 vaccine granted fast track designation by U.S. FDA
9 November 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NVX-CoV2373, the Company’s COVID-19 ...