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RSS FeedPosted 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. ...
Posted by Michael Wonder on 29 May 2025
Capsida receives FDA fast track designation for its potential first in class IV administered gene therapy for STXBP1 developmental and epileptic encephalopathy
29 May 2025 - Capsida previously received FDA orphan drug designation and IND clearance to initiate the SYNRGY Phase 1/2a ...
Posted by Michael Wonder on 28 May 2025
Experimental Drug Development Centre granted US FDA fast track designation for antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma
28 May 2025 - EBC-129 is the first made in Singapore antibody-drug conjugate to enter clinical development. ...
Posted by Michael Wonder on 27 May 2025
Teva celiac disease candidate granted fast track designation by US FDA
27 May 2025 - Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac ...
Posted by Michael Wonder on 19 May 2025
Zai Lab receives US FDA fast track designation for ZL-1310, a DLL3 targeted antibody drug conjugate, for treatment of extensive stage small cell lung cancer
19 May 2025 - The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung ...
Posted by Michael Wonder on 14 May 2025
FDA fast tracks therapy for radiation-induced dry mouth
7 May 2025 - A therapy under development at the University of Wisconsin School of Medicine and Public Health to ...
Posted by Michael Wonder on 07 May 2025
Adcentrx Therapeutics granted fast track designation for ADRX-0706 nectin-4 antibody drug conjugate for the treatment of advanced cervical cancer
6 May 2025 - Adcentrx Therapeutics today announced that the US FDA has granted fast track designation to its lead ...