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RSS FeedPosted by Michael Wonder on 08 Jul 2019
Prevail Therapeutics receives U.S. FDA fast track designation for PR001 for the treatment of Parkinson’s disease patients with a GBA1 mutation
8 July 2019 - Company plans to initiate Phase 1/2 clinical trial in the second half of 2019. ...
Posted by Michael Wonder on 28 Jun 2019
Arrowhead Pharmaceuticals receives fast track designation for ARO-AAT for treatment of alfa-1 liver disease
27 June 2019 - Arrowhead Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to ARO-AAT, the company’s ...
Posted by Michael Wonder on 26 Jun 2019
U.S. FDA grants fast track designation to empagliflozin for the treatment of chronic heart failure
26 June 2019 - FDA's Fast Track designation for empagliflozin underscores the urgent need for new potential treatment options for the ...
Posted by Michael Wonder on 19 Jun 2019
FDA grants fast track designation for Torque's first deep-primed T cell cancer immunotherapy program, TRQ-1501
18 June 2019 - Torque announced today that the U.S. FDA granted fast track designation for Torque's first Deep-Primed T cell ...
Posted by Michael Wonder on 19 Jun 2019
Abeona Therapeutics receives FDA fast track designation for ABO-202 AAV9 gene therapy in CLN1 disease
18 June 2019 - Abeona Therapeutics today announced that the U.S. Food and FDA has granted fast track designation to its ...
Posted by Michael Wonder on 05 Jun 2019
Sierra announces momelotinib granted FDA fast track designation
5 June 2019 - Fast Track designation highlights the potential for momelotinib to address the significant unmet needs of patients with ...
Posted by Michael Wonder on 04 Jun 2019
SpringWorks Therapeutics announces FDA fast track designation for PD-0325901 for the treatment of a severe form of neurofibromatosis type 1
3 June 2019 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for PD-0325901, an investigational, ...
Posted by Michael Wonder on 30 May 2019
Zymeworks' lead asset, ZW25, granted fast track designation from the FDA
29 May 2019 - Zymeworks today announced that the U.S. FDA has granted fast track designation to ZW25, a novel azymetric ...
Posted by Michael Wonder on 30 May 2019
Arvinas receives fast track designation for its targeted protein degrader ARV-110 as a treatment for men with metastatic castration-resistant prostate cancer
29 May 2019 - Arvinas today announced that its lead Protac protein degrader, ARV-110, has been granted fast track designation by ...
Posted by Michael Wonder on 30 May 2019
Imara announces FDA fast track designation for IMR-687 for the treatment of sickle cell disease
29 May 2019 - Imara today announced that the U.S. FDA has granted fast track designation to IMR-687, the company’s ...
Posted by Michael Wonder on 29 May 2019
U.S. FDA grants priority review for Vascepa (icosapent ethyl) supplemental new drug application seeking cardiovascular risk reduction indication
29 May 2019 - PDUFA date assigned is 28 September 2019, four months sooner than expected. ...
Posted by Michael Wonder on 29 May 2019
Sermonix receives FDA fast track designation for investigational drug lasofoxifene
28 May 2019 - Designation allows for expedited development and review of lasofoxifene as a potential precision medicine treatment for women ...
Posted by Michael Wonder on 18 May 2019
Athersys announces fast track designation from FDA for MultiStem program for acute respiratory distress syndrome
14 May 2019 - Athersys announced today that its clinical program evaluating MultiStem cell therapy for the treatment of acute respiratory ...
Posted by Michael Wonder on 15 May 2019
Homology Medicines announces FDA fast track designation for HMI-102 gene therapy development candidate for adults with PKU
14 May 2019 - Company provides details of pheNIX, the first gene therapy trial for PKU, and remains on track to ...
Posted by Michael Wonder on 14 May 2019
Cellectar receives FDA fast track designation for CLR 131 in relapsed or refractory multiple myeloma
13 May 2019 - Designation could accelerate CLR 131 development and underscores the need for new treatments. ...