Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Sep 2025
Anti-MTBR (microtubule binding region) tau antibody etalanetug granted FDA fast track designation
16 September 2025 - Eisai announced today that etalanetug (E2814), an investigational anti-MTBR (microtubule binding region) tau antibody, was granted fast ...
Posted by Michael Wonder on 17 Sep 2025
FDA grants fast track designation to Corbus Pharmaceuticals’ nectin-4 targeting ADC CRB-701 in head and neck squamous cell carcinoma
16 September 2025 - Corbus Pharmaceuticals announced today that the US FDA has granted fast track designation to CRB-701 for the ...
Posted by Michael Wonder on 12 Sep 2025
Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration
11 September 2025 - Designation earned for a one time intravitreal gene therapy with the potential to eliminate treatment burden for ...
Posted by Michael Wonder on 10 Sep 2025
Greenwich LifeSciences’ GLSI-100 granted US FDA fast track designation
10 September 2025 - Greenwich LifeSciences today announced that FDA has granted fast track designation for GLSI-100 in the HLA-A*02 patient ...
Posted by Michael Wonder on 10 Sep 2025
Teva’s emrusolmin granted US FDA fast track designation for treatment of multiple system atrophy
9 September 2025 - Teva Pharmaceuticals today announced that the US FDA granted fast track designation for Teva’s investigational therapy emrusolmin ...
Posted by Michael Wonder on 10 Sep 2025
FDA grants fast track designation to NS-229 for the treatment of eosinophilic granulomatosis with polyangiitis
9 September 2025 - NS Pharma, a subsidiary of Nippon Shinyaku, announced today that the US FDA has granted fast track ...
Posted by Michael Wonder on 05 Sep 2025
CERo Therapeutics receives FDA fast track designation for CER-1236 in acute myeloid leukaemia
5 September 2025 - CERo Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 29 Aug 2025
Tolremo Therapeutics receives two FDA fast track designations for TT125-802 in pretreated, advanced or metastatic NSCLC with either an EGFR or a KRAS G12C mutation
28 August 2025 - – Tolremo Therapeutics today announced that their lead candidate, TT125-802, received two fast track designations from the ...
Posted by Michael Wonder on 27 Aug 2025
Cereno Scientific granted FDA fast track designation for CS1 in rare disease pulmonary arterial hypertension
26 August 2025 - Cereno Scientific today announced that the US FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 26 Aug 2025
Allarity Therapeutics granted FDA fast track designation for stenoparib for the treatment of advanced ovarian cancer
26 August 2025 - Allarity Therapeutics today announced that the US FDA has granted fast track designation to stenoparib, its investigational ...
Posted by Michael Wonder on 21 Aug 2025
BioAegis Therapeutics awarded second FDA fast track designation for recombinant human gelsolin to treat inflammasome driven decompression sickness
20 August 2025 - Second fast rrack designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven ...
Posted by Michael Wonder on 20 Aug 2025
Aldeyra Therapeutics receives fast track designation for ADX‑2191 for the treatment of retinitis pigmentosa
19 August 2025 - 025-- Aldeyra Therapeutics today announced that the US FDA has granted fast track designation for ADX-2191 (methotrexate ...