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RSS FeedPosted by Michael Wonder on 03 Oct 2024
Volastra Therapeutics granted FDA fast track designation for novel KIF18A inhibitor in ovarian cancer
2 October 2024 - Volastra Therapeutics today announced that the US FDA has granted fast track designation to VLS-1488, the company’s ...
Posted by Michael Wonder on 02 Oct 2024
Sagimet receives FDA breakthrough therapy designation for denifanstat in MASH
1 October 2024 - Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH. ...
Posted by Michael Wonder on 02 Oct 2024
Zilganersen granted US FDA fast track designation for people living with Alexander disease
1 October 2024 - Zilganersen is the first investigational medicine in clinical development for adults and children living with Alexander disease, ...
Posted by Michael Wonder on 27 Sep 2024
FDA grants fast track designation to PTC518 Huntington's disease program
26 September 2024 - PTC Therapeutics announced today that the FDA has granted fast track designation to the PTC518 program for ...
Posted by Michael Wonder on 24 Sep 2024
Elevation Oncology receives fast track designation from the FDA for EO-3021 for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction cancer expressing Claudin 18.2
23 September 2024 - Elevation Oncology today announced that the US FDA has granted fast track designation to EO-3021, a differentiated ...
Posted by Michael Wonder on 24 Sep 2024
Priovant Therapeutics announces receipt of fast track designation from FDA for brepocitinib in non-anterior non-infectious uveitis
23 September 2024 - First patients have been dosed in CLARITY, a Phase 3 study evaluating brepocitinib in non-anterior non-infectious uveitis. ...
Posted by Michael Wonder on 21 Sep 2024
FDA fast track designation for narmafotinib in advanced pancreatic cancer
19 September 2024 - Amplia Therapeutics is pleased to announce that the US FDA has granted fast track designation to Amplia's ...
Posted by Michael Wonder on 19 Sep 2024
Azitra receives fast track designation for ATR-04 for skin rash from EGFR inhibitors
18 September 2024 - Azitra today announced the US FDA has granted fast track designation for topically applied ATR-04 to treat ...
Posted by Michael Wonder on 19 Sep 2024
Glycomine receives FDA fast track designation for GLM101 for the treatment of PMM2-CDG
18 September 2024 - Glycomine announced today that the US FDA has granted fast track designation for GLM101, a mannose-1-phosphate ...
Posted by Michael Wonder on 19 Sep 2024
ImCheck receives FDA fast track designation for ICT01 in combination with azacitidine and venetoclax in first-line acute myeloid leukaemia for patients unfit for induction chemotherapy treatment
18 September 2024 - ICT01, a humanised anti-butyrophilin 3A monoclonal antibody designed to selectively activate Vγ9Vδ2 T cells, has shown ...
Posted by Michael Wonder on 06 Sep 2024
Sun Pharma and Moebius Medical announce fast track designation granted for MM-II for the treatment of osteoarthritis knee pain
6 September 2024 - Sun Pharma and Moebius Medical announced that the US FDA has granted fast track designation to ...
Posted by Michael Wonder on 05 Sep 2024
Perspective Therapeutics granted fast track designation for VMT01 for the diagnosis and treatment of MC1R positive melanoma
5 September 2024 - Perspective Therapeutics today announced that the US FDA granted fast track designation for the development of ...
Posted by Michael Wonder on 05 Sep 2024
Synthekine granted US FDA fast track designation for CD19 CAR-T and orthogonal IL-2 investigational therapy, SYNCAR-001 + STK-009, for the treatment of lupus without lymphodepletion
4 September 2024 - Synthekine today announced that the US FDA has granted fast track designation to SYNCAR-001 + STK-009, ...
Posted by Michael Wonder on 05 Sep 2024
Innovent receives fast track designation from the US FDA for IBI363 (PD-1/IL-2α bispecific antibody fusion protein) as monotherapy for advanced melanoma
4 September 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its PD-1/IL-2α bispecific antibody ...
Posted by Michael Wonder on 03 Sep 2024
Caribou Biosciences announces the FDA has granted fast track designations to CB-010 in refractory SLE and to CB-012 in relapsed or refractory AML
3 September 2024 - Additional FDA designation for CB-010 following earlier RMAT and fast track designations in B-NHL. ...