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RSS FeedPosted by Michael Wonder on 28 Jul 2021
Lyndra Therapeutics’ investigational oral, weekly opioid use disorder treatment LYN-014 granted fast track designation by FDA
27 July 2021 - LYN-014 has the potential to address significant public health concerns about access to opioid use disorder treatment and ...
Posted by Michael Wonder on 19 Jul 2021
G1 Therapeutics receives fast track designation from U.S. Food and Drug Administration for Cosela (trilaciclib) in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer
19 July 2021 - G1 Therapeutics today announced that the U.S. FDA has granted fast track designation to Cosela (trilaciclib) ...
Posted by Michael Wonder on 19 Jul 2021
BlueRock Therapeutics receives FDA fast track designation for DA01 in the treatment of advanced Parkinson’s disease
19 July 2021 - BlueRock Therapeutics announced that the U.S. FDA has granted fast track designation for DA01 for advanced Parkinson’s ...
Posted by Michael Wonder on 14 Jul 2021
FDA grants Alkeus Pharmaceuticals breakthrough therapy designation for ALK-001 (C20-D3-vitamin A) for the treatment of Stargardt disease
14 July 2021 - Only drug to receive breakthrough therapy designation for Stargardt disease. ...
Posted by Michael Wonder on 08 Jul 2021
Lysogene announces FDA fast track designation for LYS-GM101 gene therapy for the treatment of GM1 gangliosidosis
8 July 2021 - Lysogene today announced that the U.S. FDA has granted fast track designation to its LYS-GM101 program, which ...
Posted by Michael Wonder on 06 Jul 2021
Opthea’s OPT-302 granted FDA fast track designation for wet age-related macular degeneration
6 July 2021 - FDA’s Fast Track Designation for OPT-302 offers benefits to expedite the OPT-302 Phase 3 clinical program and ...
Posted by Michael Wonder on 30 Jun 2021
Allogene Therapeutics granted FDA fast track designation for ALLO-605, the first TurboCAR T Cell therapy, for the treatment of relapsed/refractory multiple myeloma
30 June 2021 - TurboCAR technology provides selective, programmable cytokine signaling designed to improve function and potency of AlloCAR T cells. ...
Posted by Michael Wonder on 30 Jun 2021
Cend Therapeutics’ CEND-1 granted fast track designation for pancreatic cancer
29 June 2021 - The US FDA has granted fast track development status for Cend’s investigational drug, CEND-1, for the ...
Posted by Michael Wonder on 30 Jun 2021
FDA grants fast track designation to CNS Pharmaceuticals for berubicin for the treatment of recurrent glioblastoma multiforme
29 June 2021 - FDA fast track designation for berubicin highlights the serious unmet medical need for new treatments for glioblastoma ...
Posted by Michael Wonder on 28 Jun 2021
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in factor VII deficiency
28 June 2021 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for Marzeptacog alfa (activated), MarzAA, ...
Posted by Michael Wonder on 28 Jun 2021
AskBio receives FDA fast track designation for LION-101, a novel investigational AAV gene therapy for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
28 June 2021 - LGMD2I/R9 is a rare form of muscular dystrophy with no approved therapies. ...
Posted by Michael Wonder on 28 Jun 2021
SNDX-5613 granted FDA fast track designation for the treatment of relapsed/refractory acute leukemias
28 June 2021 - Syndax Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to SNDX-5613 for the ...
Posted by Michael Wonder on 22 Jun 2021
Targovax receives fast track designation for ONCOS-102 in melanoma
22 June 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in PD-1-refractory ...
Posted by Michael Wonder on 17 Jun 2021
Applied Therapeutics granted fast track designation by FDA for AT-007 for galactosaemia
17 June 2021 - Applied Therapeutics today announced that the U.S. FDA has granted fast track designation to AT-007 for the ...
Posted by Michael Wonder on 15 Jun 2021
Cerevel Therapeutics announces fast track designation granted by the US FDA to CVL-871 for the treatment of dementia related apathy
15 June 2021 - Cerevel Therapeutics announced that the US FDA has granted fast track designation to CVL-871, a D1/D5 ...