Blog
RSS FeedPosted by Michael Wonder on 10 Oct 2025
Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma
9 October 2025 - Adcendo ApS today announced that the US FDA has granted fast track designation to ADCE-D01 for ...
Posted by Michael Wonder on 08 Oct 2025
Werewolf Therapeutics receives fast track designation from the US FDA for WTX-124, an investigational therapy for the treatment of cancer
8 October 2025 - Werewolf Therapeutics today announced that the Company has received fast track designation for the use of WTX-124 ...
Posted by Michael Wonder on 08 Oct 2025
Vivace Therapeutics' VT3989 granted fast track designation by the US FDA for the treatment of mesothelioma
8 October 2025 - Vivace Therapeutics today announced that the US FDA has granted fast track designation to VT3989, the company's ...
Posted by Michael Wonder on 07 Oct 2025
EG 427 receives US FDA fast track designation for EG110A DNA medicine in neurogenic bladder patients
6 October 2025 - EG 427 announced today that the US FDA granted fast track designation to EG110A, its novel DNA ...
Posted by Michael Wonder on 04 Oct 2025
Alzinova receives fast track designation from US FDA for ALZ-101 in Alzheimer’s disease
4 October 2025 - Alzinova today announces that the US FDA has granted fast track designation for the company’s vaccine candidate ...
Posted by Michael Wonder on 04 Oct 2025
Ensem Therapeutics announces ETX-636 granted fast track designation by the FDA for advanced breast cancer
1 October 2025 - Ensem Therapeutics today announced the US FDA granted fast track designation to its clinical stage pan mutant-specific ...
Posted by Michael Wonder on 03 Oct 2025
Alto Neuroscience receives FDA fast track designation for ALTO-101 for the treatment of cognitive impairment associated with schizophrenia
3 October 2025 - Alto Neuroscience today announced that the US FDA has granted fast track designation to ALTO-101 for the ...
Posted by Michael Wonder on 02 Oct 2025
Calico Life Sciences announces US FDA fast track designation for investigational treatment of autosomal dominant polycystic kidney disease
2 October 2025 - Calico Life Sciences today announced the US FDA granted fast track designation for ABBV-CLS-628, an investigational therapy ...
Posted by Michael Wonder on 01 Oct 2025
Bristol Myers Squibb’s anti-MTBR-tau targeting antibody, BMS-986446, granted fast track designation by US FDA for the treatment of Alzheimer’s disease
1 October 2025 - Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of ...
Posted by Michael Wonder on 30 Sep 2025
Umoja Biopharma announces that UB-VV111 receives FDA fast track designation for relapsed/refractory B-cell malignancies
30 September 2025 - Umoja Biopharma announced today that the US FDA has granted fast track designation to UB-VV111 for the ...
Posted by Michael Wonder on 30 Sep 2025
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from methamphetamine
30 September 2025 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 25 Sep 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
Posted by Michael Wonder on 23 Sep 2025
Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1
23 September 2025 - Designation earned for one time AAV gene therapy SAR446268, designed to silence DMPK expression. ...
Posted by Michael Wonder on 23 Sep 2025
MavriX Bio receives FDA fast track designation for MVX-220 for treatment of Angelman syndrome
22 September 2025 - MavriX Bio today announced that the US FDA has granted fast track designation for MVX-220, an investigational ...
Posted by Michael Wonder on 18 Sep 2025
Minovia Therapeutics receives FDA fast track designation for MNV-201 in myelodysplastic syndrome
18 September 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...