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RSS FeedPosted by Michael Wonder on 29 Sep 2020
Infinity receives fast track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for first-line treatment of advanced triple negative breast cancer
29 September 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for eganelisib (IPI-549) ...
Posted by Michael Wonder on 28 Sep 2020
AbbVie receives orphan drug and fast track designations from the U.S. FDA for elezanumab, an investigational monoclonal antibody RGMa inhibitor, for the treatment of spinal cord injury
28 September 2020 - Elezanumab (ABT-555) is an investigational treatment being evaluated in neurological disorders, including treatment following spinal cord injury. ...
Posted by Michael Wonder on 27 Sep 2020
Precision BioSciences receives fast track designation from U.S. FDA for PBCAR269A, an investigational allogeneic CAR-T therapy for relapsed/refractory multiple myeloma
9 September 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to PBCAR269A for the treatment ...
Posted by Michael Wonder on 24 Sep 2020
Leap Therapeutics announces FDA fast track designation granted to DKN-01 for the treatment of gastric and gastro-esophageal junction cancer
24 September 2020 - Leap Therapeutics today announced that the U.S. FDA has granted fast track designation to DKN-01 for the ...
Posted by Michael Wonder on 22 Sep 2020
Gyroscope Therapeutics granted FDA fast track designation for GT005, an investigational gene therapy for dry age-related macular degeneration
22 September 2020 - Gyroscope Therapeutics today announced that the U.S. FDA has granted fast track designation to GT005 for the ...
Posted by Michael Wonder on 15 Sep 2020
Plus Therapeutics receives fast track designation from FDA for its novel glioblastoma treatment
15 September 2020 - Plus Therapeutics today announced that the U.S. FDA has granted the Company fast track designation for its ...
Posted by Michael Wonder on 15 Sep 2020
US FDA grants fast track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack
15 September 2020 - This fast track designation for empagliflozin emphasises the urgent need for potential treatments that may improve outcomes ...
Posted by Michael Wonder on 14 Sep 2020
ESSA Pharma announces fast track designation granted by the FDA to EPI-7386 for the treatment of metastatic castration-resistant prostate cancer
14 September 2020 - ESSA Pharma today announced that the US FDA granted fast track designation to EPI-7386, its oral ...
Posted by Michael Wonder on 10 Sep 2020
Terns Pharmaceuticals receives fast track designation for TERN-201 as a treatment for NASH
10 September 2020 - Clinical trial of semicarbazide-sensitive amine oxidase inhibitor TERN-201 in NASH patients planned for early 2021. ...
Posted by Michael Wonder on 31 Aug 2020
VelosBio announces FDA fast track and orphan drug designations for VLS-101 in patients with mantle cell lymphoma
31 August 2020 - VelosBio today announced that the U.S. FDA has granted the company fast track and orphan drug designation ...
Posted by Michael Wonder on 28 Aug 2020
Rocket Pharmaceuticals receives FDA fast track designation for RP-L401 gene therapy for infantile malignant osteopetrosis
27 August 2020 - Rocket’s fifth gene therapy program receives fast track designation. ...
Posted by Michael Wonder on 26 Aug 2020
Metacrine announces MET409 receives FDA fast track designation for the treatment of NASH
25 August 2020 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET409, the company’s lead ...
Posted by Michael Wonder on 25 Aug 2020
Turning Point Therapeutics granted fast-track designation for repotrectinib in NTRK positive TKI pre-treated advanced solid tumours
24 August 2020 - Turning Point Therapeutics today announced the FDA granted a third fast-track designation to its lead drug ...
Posted by Michael Wonder on 24 Aug 2020
Trump considers fast-tracking UK COVID-19 vaccine before US election
24 August 2020 - Move comes as FDA gives emergency authorisation for use of plasma from recovered patients. ...
Posted by Michael Wonder on 20 Aug 2020
Polaryx Therapeutics receives FDA fast track designation to PLX-200 for the treatment of patients with juvenile neuronal ceroid lipofuscinosis
20 August 2020 - Polaryx Therapeutics announced today that the U.S. FDA has granted fast track designation to PLX-200 for ...