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RSS FeedPosted 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. ...
Posted by Michael Wonder on 29 Aug 2024
Life Molecular Imaging receives FDA fast track designation for [18F]PI-2620 in Tau PET imaging across three neurodegenerative conditions
28 August 2024 - Life Molecular Imaging is pleased to announce that the US FDA granted fast track designation to [18F]PI-2620 ...
Posted by Michael Wonder on 27 Aug 2024
FDA grants fast track designation for bexmarilimab
26 August 2024 - Faron Pharmaceuticals today announces that their lead candidate bexmarilimab has been granted fast track designation for the ...
Posted by Michael Wonder on 26 Aug 2024
BeiGene’s BGB-16673 receives US FDA fast track designation for CLL/SLL
26 August 2024 - Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with ...
Posted by Michael Wonder on 25 Aug 2024
FDA grants fast track designation to Aveta Biomics’ drug APG-157 for neo-adjuvant treatment of head and neck cancer
22 August 2024 - Aveta Biomics is pleased to announce that the US FDA has granted fast track designation to APG-157, ...