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RSS FeedPosted by Michael Wonder on 09 Sep 2021
Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations
9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...
Posted by Michael Wonder on 08 Sep 2021
HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU
8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...
Posted by Michael Wonder on 02 Sep 2021
Novartis gets FDA fast track designation for LNA043 in knee osteoarthritis
2 September 2021 - Novartis AG on Thursday said the U.S. FDA granted fast track designation to LNA043 for the ...
Posted by Michael Wonder on 24 Aug 2021
Humanetics Corporation’s BIO 300 receives fast track designation from FDA
24 August 2021 - Humanetics announced today that BIO 300, a drug under development to increase survival in persons exposed to ...
Posted by Michael Wonder on 19 Aug 2021
Senhwa's silmitasertib receives US FDA fast track designation for the treatment of recurrent sonic hedgehog driven medulloblastoma
19 August 2021 - Senhwa Biosciences today announced that the US FDA has granted fast track designation for silmitasertib, a highly ...
Posted by Michael Wonder on 18 Aug 2021
Sutro Biopharma announces STRO-002 FDA fast track designation for patients with advanced ovarian cancer
18 August 2021 - Sutro Biopharma today announced that the U.S. FDA has granted fast track designation for STRO-002, a folate ...
Posted by Michael Wonder on 16 Aug 2021
Edgewise receives U.S. FDA fast track designation for EDG-5506 for the treatment of individuals with Becker muscular dystrophy
16 August 2021 - EDG-5506, a drug candidate designed to arrest muscle fibre breakdown in Becker and Duchenne muscular dystrophy, continues to ...
Posted by Michael Wonder on 16 Aug 2021
Carrick Therapeutics receives FDA fast track designations for two samuraciclib combinations for the treatment of HR+, HER2- advanced breast cancer and locally advanced or metastatic triple negative breast cancer
16 August 2021 - Carrick Therapeutics today announced that the U.S. FDA has granted Fast Track designations to samuraciclib in combination ...
Posted by Michael Wonder on 16 Aug 2021
InxMed's IN10018 receives U.S. FDA fast track designation for the treatment of platinum-resistant ovarian cancer
16 August 2021 - InxMed announced today the U.S. FDA has granted fast track designation to IN10018 for the treatment of ...
Posted by Michael Wonder on 12 Aug 2021
VTX-801 receives U.S. FDA fast track designation for the treatment of Wilson disease
12 August 2021 - Vivet Therapeutics and Pfizer today announced the U.S. FDA has granted fast track designation to VTX-801, ...
Posted by Michael Wonder on 11 Aug 2021
Turning Point Therapeutics granted sixth regulatory designation for repotrectinib
11 August 2021 - Fast track designation granted by FDA in ROS1 positive advanced non-small-cell lung cancer patients pretreated with one ...
Posted by Michael Wonder on 09 Aug 2021
Calliditas receives FDA fast track designation for setanaxib in PBC
9 August 2021 - Calliditas Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead NOX ...
Posted by Michael Wonder on 06 Aug 2021
Actuate Therapeutics announces FDA fast track designation for 9-ING-41 for treatment of pancreatic cancer
5 August 2021 - Actuate Therapeutics today announced that the U.S. FDA has granted fast track designation for 9-ING-41 for treatment ...
Posted by Michael Wonder on 05 Aug 2021
MT-3921 granted FDA fast track designation for treatment of spinal cord injury
4 August 2021 - Mitsubishi Tanabe Pharma announced today that Mitsubishi Tanabe Pharma Development America has received fast track designation ...
Posted by Michael Wonder on 03 Aug 2021
Moderna receives FDA fast track designation for respiratory syncytial virus vaccine (mRNA-1345)
3 August 2021 - Moderna today announced that the U.S. FDA has granted fast track designation for mRNA-1345, its investigational ...