Blog
RSS FeedPosted by Michael Wonder on 06 Jan 2023
Bicycle Therapeutics announces FDA fast track designation granted to BT8009 for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer
4 January 2023 - Bicycle Therapeutics today announced that the US FDA has granted fast track designation to Bicycle’s BT8009 ...
Posted by Michael Wonder on 06 Jan 2023
Azafaros receives fast track designation for lead asset AZ-3102
5 January 2023 - Azafaros today announced that the FDA has granted fast track designation for the investigation of AZ-3102 for ...
Posted by Michael Wonder on 05 Jan 2023
Sedana Medical receives FDA fast track designation in the US
4 January 2023 - Sedana Medical today announces that the US FDA has granted fast track designation for the evaluation of ...
Posted by Michael Wonder on 21 Dec 2022
FDA grants fast track to Edesa Biotech's ARDS drug candidate
20 December 2022 - Edesa Biotech has received fast track designation from the US FDA for its monoclonal antibody candidate, EB05. ...
Posted by Michael Wonder on 13 Dec 2022
PharmaJet Partner Immunomic Therapeutics receives FDA fast track designation for pDNA vaccine for skin cancer
13 December 2022 - Vaccine exclusively delivered with the PharmaJet Stratis needle-free injection system. ...
Posted by Michael Wonder on 10 Dec 2022
Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza
9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...
Posted by Michael Wonder on 07 Dec 2022
Moleculin granted FDA fast track designation of WP1122 for the treatment of glioblastoma multiforme
7 December 2022 - Moleculin Biotech today announced that the US FDA has granted fast track designation of WP1122 for the ...
Posted by Michael Wonder on 06 Dec 2022
SQZ Biotechnologies receives FDA fast track designation for its eAPC therapeutic candidate for treatment of HPV16 positive tumours
6 December 2022 - Stable disease observed in two out of four evaluable patients in eAPC Phase 1/2 trial including a ...
Posted by Michael Wonder on 06 Dec 2022
Vistagen receives FDA fast track designation for development of PH10 to treat major depressive disorder
6 December 2022 - Vistagen today announced the US FDA has granted fast track designation for the development of PH10, ...
Posted by Michael Wonder on 06 Dec 2022
Istesso announces FDA fast track and orphan drug designation for MBS2320
5 December 2022 - Istesso today announces that the US FDA has granted fast track designation for Istesso’s investigational metabolic ...
Posted by Michael Wonder on 06 Dec 2022
IDEAYA Biosciences receives fast track designation for darovasertib combination therapy with crizotinib for the treatment of metastatic uveal melanoma
5 December 2022 - Fast track designation granted by US FDA for evaluation of darovasertib in combination with crizotinib in adult ...
Posted by Michael Wonder on 01 Dec 2022
FDA grants fast track designation to Nuvectis Pharma's NXP800 for the treatment of platinum-resistant, ARID1A mutated ovarian carcinoma
1 December 2022 - Nuvectis Pharma today announced that the US FDA has granted fast track designation to NXP800 for the ...
Posted by Michael Wonder on 01 Dec 2022
Oncolytics Biotech receives FDA fast track designation for the treatment of advanced/metastatic pancreatic cancer
1 December 2022 - FDA fast rack designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective ...
Posted by Michael Wonder on 29 Nov 2022
Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy
29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...
Posted by Michael Wonder on 29 Nov 2022
Aravive announces fast track designation of batiraxcept for treatment of clear cell renal cell carcinoma
29 November 2022 - FDA decision based on new Phase 1b data. ...