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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Aug 2021
Alkermes receives FDA fast track designation for nemvaleukin alfa for the treatment of mucosal melanoma
2 August 2021 - Alkermes today announced that the U.S. FDA has granted fast track designation to nemvaleukin alfa, the ...
Posted by Michael Wonder on 30 Jul 2021
Erytech granted U.S. FDA fast track designation for Eryaspase in hypersensitive ALL
29 July 2021 - Fast track designation for eryaspase underscores the need for new treatment options for patients who developed ...
Posted by Michael Wonder on 28 Jul 2021
Apic Bio receives FDA fast track designation for APB-102 for the treatment of patients with SOD1 ALS
28 July 2021 - Apic Bio today announced that the U.S. FDA has granted fast track designation to APB-102, the ...
Posted 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) ...