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RSS FeedPosted 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 ...
Posted by Michael Wonder on 30 Nov 2023
Oxford BioTherapeutics announces partner Boehringer Ingelheim received US FDA fast track designation for BI 764532 for the potential treatment of advanced or metastatic large-cell neuroendocrine carcinoma of the lung
29 November 2023 - This is the third fast track designation for BI 764532. ...
Posted by Michael Wonder on 29 Nov 2023
eFFECTOR receives US FDA fast track designation for zotatifin in combination with fulvestrant and abemaciclib for treatment of ER positive/HER2 negative advanced metastatic breast cancer
28 November 2023 - Designation is for second or third-line treatment of patients with disease progression following treatment with endocrine therapy ...
Posted by Michael Wonder on 28 Nov 2023
FDA fast track designation granted for Vaxinia trial program
28 November 2023 - FDA fast track designation for bile duct cancer granted for CF33-hNIS (Vaxinia) MAST clinical program. ...
Posted by Michael Wonder on 28 Nov 2023
Genelux Corporation receives FDA fast track designation for olvi-vec in platinum resistant/refractory ovarian cancer
27 November 2023 - Pivotal Phase 3 study of olvi-vec in platinum resistant/refractory ovarian cancer initiated in September 2022. ...
Posted by Michael Wonder on 23 Nov 2023
Alladapt Immunotherapeutics receives FDA fast track designation for ADP101 for the treatment of mono- and multi-food allergies
22 November 2023 - Phase 1/2 Harmony data for ADP101 recently presented at the 2023 American College of Asthma, Allergy and ...
Posted by Michael Wonder on 15 Nov 2023
Chemomab Therapeutics receives FDA fast track designation for CM-101 for the treatment of primary sclerosing cholangitis
15 November 2023 - CM-101's unique dual anti-fibrotic and anti-inflammatory activity has disease modifying potential in this poorly treated condition. ...
Posted by Michael Wonder on 14 Nov 2023
FDA grants fast track designation to SonALAsense’s Sonala-001 in combination with the Insightec transcranial ultrasound device for sonodynamic therapy of DIPG, a rare paediatric brain cancer
14 November 2023 - SonALAsense today announced that the US FDA has granted fast track designation to the development program of ...
Posted by Michael Wonder on 11 Nov 2023
Rznomics secures fast track designation from the US FDA for RZ-001
10 November 2023 - Rznomics announced today that it has received fast track designation from the US FDA for RZ-001, for ...
Posted by Michael Wonder on 06 Nov 2023
AviadoBio announces FDA IND clearance and fast track designation for AVB-101 for the treatment of frontotemporal dementia with progranulin mutations
6 November 2023 - AVB-101 is an investigational gene therapy delivered as a one time infusion directly to the brain, enabling ...
Posted by Michael Wonder on 31 Oct 2023
Cessation Therapeutics receives FDA fast track designation for CSX-1004 for prevention of fentanyl and fentanyl analogue overdose
31 October 2023 - If approved, CSX-1004 would be the first FDA approved therapy for prevention of fentanyl-related overdose. ...
Posted by Michael Wonder on 30 Oct 2023
Sellas Life Sciences receives fast track designation from FDA for SLS009 for treatment of relapsed/refractory peripheral T-cell lymphomas
30 October 2023 - LS009 demonstrated promising efficacy in Phase 1 Study with 36.4% clinical response in relapsed/refractory peripheral T-cell lymphomas; ...