Blog
RSS FeedPosted by Michael Wonder on 25 Aug 2020
Turning Point Therapeutics granted fast-track designation for repotrectinib in NTRK positive TKI pre-treated advanced solid tumours
24 August 2020 - Turning Point Therapeutics today announced the FDA granted a third fast-track designation to its lead drug ...
Posted by Michael Wonder on 24 Aug 2020
Trump considers fast-tracking UK COVID-19 vaccine before US election
24 August 2020 - Move comes as FDA gives emergency authorisation for use of plasma from recovered patients. ...
Posted by Michael Wonder on 20 Aug 2020
Polaryx Therapeutics receives FDA fast track designation to PLX-200 for the treatment of patients with juvenile neuronal ceroid lipofuscinosis
20 August 2020 - Polaryx Therapeutics announced today that the U.S. FDA has granted fast track designation to PLX-200 for ...
Posted by Michael Wonder on 20 Aug 2020
Precision BioSciences receives fast track disease designation from U.S. FDA for PBCAR0191 investigational allogeneic CAR T-cell therapy
19 August 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to Precision for PBCAR0191, the ...
Posted by Michael Wonder on 20 Aug 2020
US FDA awards fast track designation to paxalisib for glioblastoma
20 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has granted fast track designation to ...
Posted by Michael Wonder on 14 Aug 2020
ANTI-PD-1/CTLA-4 bi-specific antibody (AK104) of Akeso granted FDA fast track designation for recurrent and metastatic cervical cancer
13 August 2020 - Akeso today announced that the U.S. FDA has granted fast track designation for AK104, a novel anti-PD-1/CTLA-4 ...
Posted by Michael Wonder on 13 Aug 2020
4D Molecular Therapeutics receives FDA fast track designation for 4D-310 gene therapy for treatment of Fabry disease
13 August 2020 - 4D Molecular Therapeutics announced that the U.S. FDA has granted fast track designation to 4D-310 for ...
Posted by Michael Wonder on 11 Aug 2020
Mersana Therapeutics receives FDA fast track designation for XMT-1536 for the treatment of patients with platinum-resistant ovarian cancer
11 August 2020 - Mersana Therapeutics today announced that the U.S. FDA has granted fast track designation for XMT-1536, for the ...
Posted by Michael Wonder on 10 Aug 2020
Aquestive Therapeutics receives FDA fast track designation for AQST-108 (sublingual film formulation delivering systemic epinephrine) for treatment of allergic reactions including anaphylaxis
10 August 2020 - Finalising preparations for pharmacokinetic clinical trials of AQST-108. ...
Posted by Michael Wonder on 05 Aug 2020
ReViral announces FDA fast track designation granted to sisunatovir for the treatment of serious respiratory syncytial virus infection
4 August 2020 - ReViral today announced that the U.S. FDA has granted fast track designation to sisunatovir for the ...
Posted by Michael Wonder on 05 Aug 2020
Leo Pharma announces US FDA fast track designation for delgocitinib cream for the treatment of adults with moderate to severe chronic hand eczema
4 August 2020 - Leo Pharma today announced that delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, has been granted fast ...
Posted by Michael Wonder on 04 Aug 2020
Biosight granted U.S. FDA fast track designation for BST-236 for the treatment of acute myeloid leukaemia
4 August 2020 - Biosight today announced that that the U.S. FDA has granted fast track designation for BST-236 (aspacytarabine) ...
Posted by Michael Wonder on 03 Aug 2020
PolyPid granted fast track designation from FDA for D-PLEX for prevention of surgical site infections in abdominal surgery
3 August 2020 - PolyPid today announced that D-PLEX100 has received fast track designation from the U.S. FDA for the prevention ...
Posted by Michael Wonder on 03 Aug 2020
FDA grants fast track designation for BCX9930 in PNH
3 August 2020 - BioCryst Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for its oral ...
Posted by Michael Wonder on 03 Aug 2020
Imara announces IMR-687 granted fast track designation and rare paediatric disease designation for treatment of beta-thalassaemia
30 July 2020 - Imara today announced the U.S. FDA has granted fast track designation and rare paediatric disease designation for ...