Blog
RSS FeedPosted by Michael Wonder on 27 Jun 2025
Schrödinger receives fast track designation for SGR-1505 for the treatment of relapsed/refractory Waldenström's macroglobulinemia
27 June 2025 - Demonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need. ...
Posted by Michael Wonder on 18 Jun 2025
Duke Street Bio receives FDA fast track designation for DSB2455
10 June 2025 - Duke Street Bio today announced that the US FDA has granted fast track designation to DSB2455, its ...
Posted by Michael Wonder on 18 Jun 2025
BioAegis Therapeutics receives FDA fast track designation for lead product, recombinant human gelsolin, for the treatment of acute respiratory distress syndrome
17 June 2025 - BioAegis Therapeutics announces that the US FDA has granted fast track designation to its lead product candidate, ...
Posted by Michael Wonder on 17 Jun 2025
Tisento Therapeutics receives US FDA fast track designation for zagociguat for the treatment of MELA
17 June 2025 - Global Phase 2b PRIZM study of zagociguat is currently enrolling participants with MELAS. ...
Posted by Michael Wonder on 17 Jun 2025
Ferrer receives FDA fast track designation for FNP-223 in progressive supranuclear palsy
17 June 2025 - Ferrer has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development ...
Posted by Michael Wonder on 16 Jun 2025
SolasCure receives FDA fast track designation for Aurase wound gel to treat calciphylaxis ulcers
16 June 2025 - Solascure today announced that the US FDA has granted fast track designation for its investigational Aurase wound ...
Posted by Michael Wonder on 12 Jun 2025
Sumitomo Pharma America announces that nuvisertib (TP-3654) has received FDA fast track designation for the treatment of myelofibrosis
12 June 2025 - Nuvisertib (TP-3654), an investigational highly selective oral PIM1 kinase inhibitor, is being evaluated in patients with ...
Posted by Michael Wonder on 12 Jun 2025
Radiopharm Theranostics granted US FDA fast track designation for RAD101 imaging in brain metastases
11 June 2025 - Radiopharm Theranostics today announced that the US FDA has granted fast track designation for RAD101 to ...
Posted by Michael Wonder on 11 Jun 2025
Cantargia’s nadunolimab antibody awarded US FDA fast track designation
11 June 2025 - Cantargia today announced that the US FDA has granted fast track designation to nadunolimab, Cantargia's anti-IL1RAP antibody ...
Posted by Michael Wonder on 10 Jun 2025
SNT-5505 awarded US FDA fast track designation
10 June 2025 - Syntara today announces that its lead candidate, SNT-5505, has been granted fast track designation by the ...
Posted by Michael Wonder on 10 Jun 2025
X4 Pharmaceuticals granted fast track designation for mavorixafor for the treatment of chronic neutropenia by US FDA
10 June 2025 - X4 Pharmaceuticals today announced that the US FDA has granted fast track designation to mavorixafor, an oral ...
Posted by Michael Wonder on 04 Jun 2025
Chimeric Therapeutics CDH17 receives FDA fast track
4 June 2025 - Chimeric Therapeutics is pleased to announce that the US FDA has granted CHM CDH17 fast track ...
Posted by Michael Wonder on 03 Jun 2025
Pheast Therapeutics receives FDA fast track designation for PHST001 for the treatment of ovarian cancer
3 June 2025 - Pheast Therapeutics today announced that the US FDA has granted fast track designation to PHST001 for ...
Posted by Michael Wonder on 03 Jun 2025
Amylyx Pharmaceuticals receives US FDA fast track designation for AMX0114 for the treatment of amyotrophic lateral sclerosis
3 June 2025 - AMX0114 is an Amylyx developed antisense oligonucleotide designed to target calpain-2, a key contributor to the ...
Posted by Michael Wonder on 29 May 2025
Zydus receives US FDA fast track designation for usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis
28 May 2025 - Usnoflast has previously also received orphan drug designation from the US FDA. ...