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RSS FeedPosted 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 ...
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 ...