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RSS FeedPosted by Michael Wonder on 02 Oct 2020
FDA grants fast track designation to Calibr’s ‘switchable’ CAR-T cell cancer therapy, CLBR001 + SWI019
1 October 2020 - Phase 1 clinical trial is now enrolling patients with blood cancers. ...
Posted by Michael Wonder on 02 Oct 2020
Pfizer receives FDA fast track designation for Duchenne muscular dystrophy investigational gene therapy
1 October 2020 - Pfizer today announced that its investigational gene therapy candidate (PF-06939926) being developed to treat Duchenne muscular dystrophy ...
Posted by Michael Wonder on 02 Oct 2020
FDA grants fast track status to Aegle Therapeutics' AGLE-102 for the treatment of dystrophic epidermolysis bullosa
1 October 2020 - Aegle Therapeutics Corporation today announced the U.S. FDA has granted fast track designation to AGLE-102 for ...
Posted 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 ...