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RSS FeedPosted by Michael Wonder on 31 Jul 2025
Revalesio receives FDA fast track designation for RNS60 for the treatment of acute ischaemic stroke
31 July 2025 - Revalesio today announced that the US FDA has granted fast track designation to RNS60, its lead investigational ...
Posted by Michael Wonder on 30 Jul 2025
Calidi Biotherapeutics receives FDA fast track designation for CLD-201 (SuperNova), a first in class stem cell loaded viral therapy for the treatment of patients with soft tissue sarcoma
29 July 2025 - Calidi Biotherapeutics today announced that it received fast track designation from the US FDA for CLD-201 (SuperNova), ...
Posted by Michael Wonder on 30 Jul 2025
Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of severe to very severe alopecia areata
29 July 2025 - Nektar Therapeutics today announced that the US FDA has granted fast track designation for rezpegaldesleukin for the ...
Posted by Michael Wonder on 28 Jul 2025
MAIA Biotechnology receives FDA’s fast track designation for ateganosine as a treatment for non-small cell lung cancer
28 July 2025 - Potential first to market small molecule telomere targeting agent targets a $34 billion non-small cell lung cancer ...
Posted by Michael Wonder on 26 Jul 2025
Shanton receives fast track designation from US FDA for refractory gout program
25 July 2025 - Shanton Pharma today announced that FDA has designated its Investigational new drug SAP-001 as a fast track ...
Posted by Michael Wonder on 24 Jul 2025
Verastem Oncology granted fast track designation for VS-7375 for the treatment of KRAS G12D mutated locally advanced or metastatic pancreatic cancer
24 July 2025 - Enrollment is on-going in US Phase 1/2a trial for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, ...
Posted by Michael Wonder on 24 Jul 2025
Solid Biosciences receives FDA fast track designation for SGT-501 first in class gene therapy for catecholaminergic polymorphic ventricular tachycardia
23 July 2025 - SGT-501 has now received FDA fast track, orphan drug and rare paediatric disease designations. ...
Posted by Michael Wonder on 23 Jul 2025
DualityBio's next generation HER3 ADC DB-1310 granted FDA fast track designation
21 July 2025 - DualityBio announced that the US FDA has granted fast track designation to its next-generation HER3 targeting antibody ...
Posted by Michael Wonder on 22 Jul 2025
ProMIS Neurosciences granted fast track designation by US FDA for PMN310 in the treatment of Alzheimer’s disease
21 July 2025 - ProMIS Neurosciences today announced that the US FDA has granted fast track designation to PMN310, the ...
Posted by Michael Wonder on 16 Jul 2025
Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
16 July 2025 - The US FDA has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for ...
Posted by Michael Wonder on 15 Jul 2025
FDA grants Zenith’s ZEN-3694 fast track status
14 July 2025 - Zenith Epigenetics is pleased to announce the designation of ZEN-3694 as a fast track product by the ...
Posted by Michael Wonder on 11 Jul 2025
FDA grants fast track designation for TRE-515 in combination with radiation therapy for the treatment of metastatic castration resistant prostate cancer
9 July 2025 - Trethera announced today that the US FDA has granted fast track designation for its novel drug, TRE-515, ...
Posted by Michael Wonder on 05 Jul 2025
Vitalgen's gene therapy drug VGN-R09b for primary Parkinson's disease receives FDA fast track designation
26 June 2025 - Shanghai Vitalgen announced that its gene therapy drug, VGN-R09b, for the treatment of primary Parkinson’s disease, has ...
Posted by Michael Wonder on 30 Jun 2025
Minovia Therapeutics announces FDA fast track and rare paediatric disease designations for MNV-201 in Pearson syndrome
30 June 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted 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. ...