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RSS FeedPosted by Michael Wonder on 09 Jan 2024
Sellas Life Sciences receives FDA fast track designation for SLS009 for treatment of relapsed/refractory acute myeloid leukaemia
9 January 2024 - Sellas Life Sciences Group today announced that the US FDA has granted fast track designation to SLS009 ...
Posted by Michael Wonder on 08 Jan 2024
Cabaletta Bio receives additional FDA fast track designations for CABA-201 in dermatomyositis and systemic sclerosis
8 January 2024 - Second and third FDA fast track designations for CABA-201, following the systemic lupus erythematosus and lupus ...
Posted by Michael Wonder on 08 Jan 2024
FDA grants Soligenix fast track designation for dusquetide in the treatment of oral lesions of Behçet's disease
8 January 2024 - Soligenix announced today that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's ...
Posted by Michael Wonder on 05 Jan 2024
ProfoundBio announces rinatabart sesutecan FDA fast track designation for patients with advanced ovarian cancer
5 January 2023 - ProfoundBio today announced that the US FDA has granted fast track designation for rinatabart sesutecan (Rina-S; ...
Posted by Michael Wonder on 27 Dec 2023
Imaging Biometrics granted FDA fast track
19 December 2023 - Imaging Biometrics is pleased to announce that the US FDA has granted fast track designation for oral ...
Posted by Michael Wonder on 27 Dec 2023
FDA grants fast track designation to Henlius’ EGFR targeting ADC HLX42 for NSCLC patients with disease progression on EGFR targeted therapies
27 December 2023 - Shanghai Henlius Biotech announced that the US FDA granted fast track designation for HLX42, an investigational EGFR ...
Posted by Michael Wonder on 18 Dec 2023
Lexeo Therapeutics granted FDA fast track designation and orphan drug designation for LX2020, an AAV based gene therapy candidate for PKP2 arrhythmogenic cardiomyopathy
18 December 2023 - Lexeo Therapeutics today announced the US FDA has granted fast track designation and orphan drug designation to ...
Posted by Michael Wonder on 15 Dec 2023
Abbisko Therapeutics announces that US FDA has granted fast track designation for its CSF-1R inhibitor pimicotinib (ABSK021)
13 December 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ...
Posted by Michael Wonder on 14 Dec 2023
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in the treatment of patients with refractory myasthenia gravis
13 December 2023 - KYV-101 is a fully human CD19 CAR T-cell therapy designed for use in patients with B ...
Posted by Michael Wonder on 12 Dec 2023
Candel Therapeutics receives FDA fast track designation for CAN-2409 in pancreatic cancer
12 December 2023 - Candel Therapeutics today announced that the US FDA granted fast track designation for its lead investigational adenovirus ...
Posted by Michael Wonder on 11 Dec 2023
Erasca granted FDA fast track designation for pan-RAF inhibitor naporafenib in patients with advanced NRAS mutated melanoma
11 December 2023 - First in class and best-in-class potential in NRAS mutated melanoma and other RAS/MAPK pathway altered solid tumours. ...
Posted by Michael Wonder on 08 Dec 2023
EnGeneIC granted FDA fast track designation for novel armed nanocell drug conjugate pancreatic cancer therapeutic
7 December 2023 - EnGeneIC has achieved a significant milestone with the granting of FDA fast track designation for its ...
Posted by Michael Wonder on 07 Dec 2023
Solid Biosciences receives FDA fast track designation for Duchenne muscular dystrophy gene therapy SGT-003
7 December 2023 - Next generation gene transfer therapy to treat Duchenne receives FDA fast track Designation. ...
Posted by Michael Wonder on 05 Dec 2023
CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high risk BCG unresponsive non-muscle invasive bladder cancer
5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...
Posted by Michael Wonder on 02 Dec 2023
Orchard Therapeutics receives US FDA fast track designation for OTL-203 in MPS-IH
30 November 2023 - Previously reported results from ongoing proof of concept study showed extensive metabolic correction, continued cognitive, motor, and ...