Kymera Therapeutics receives US FDA fast track designation for KT-333, a first in class, investigational STAT3 degrader for the treatment of relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma

18 September 2023 - KT-333 Phase 1 oncology trial ongoing with an update including initial evaluation of its clinical anti-tumour activity ...

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MorphoSys receives US FDA fast track designation for tulmimetostat in endometrial cancer

12 September 2023 - Tulmimetostat follows pelabresib (2018) and tafasitamab (2014) as the company’s third clinical program to receive fast ...

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Affimed receives FDA fast track designation for AFM13 in combination with AlloNK for the treatment of patients with relapsed or refractory Hodgkin lymphoma

12 September 2023 - Affimed today announced that the FDA has granted fast track designation to the combination of its innate ...

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Mendus receives US FDA fast track designation for vididencel in acute myeloid leukaemia

8 September 2023 - Mendus today announced that it has received fast track designation from the US FDA for the Company’s ...

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Abliva’s lead candidate KL1333 receives FDA fast track designation

4 September 2023 - Abliva today announced that the company’s lead candidate KL1333 has received fast track designation from the ...

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Taysha Gene Therapies announces fast track designation granted by US FDA for TSHA-102 in Rett syndrome

24 August 2023 - TSHA-102 has also received orphan drug and rare paediatric disease designations from the US FDA and ...

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Alentis Therapeutics receives FDA fast track designation for ALE.C04 for the treatment of Claudin-1 positive HNSCC

24 August 2023 - Fast Track designation accelerates the path to US submission for the investigational monoclonal antibody in patients with ...

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Nectero Medical receives FDA fast track designation for Nectero EAST System

24 August 2023 - Fast Track designation accelerates Nectero EAST System’s path to FDA regulatory review of a treatment for patients ...

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Comanche Biopharma receives US FDA fast track designation for CBP-4888 for the treatment of sFlt-1 mediated pre-term preeclampsia

23 August 2023 - Comanche Biopharma today announced that they have received fast track designation from the US FDA for ...

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US FDA designates PYC's lead as a fast track development program

11 August 2023 - The Company is currently evaluating the safety/tolerability and efficacy of an investigational drug candidate with disease-modifying potential ...

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PYC Therapeutics gets fast track status from FDA for retinitis pigmentosa treatment

1 August 2023 - PYC Therapeutics has received fast track designation from the US FDA for a new drug aimed ...

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FDA grants fast track designation to IVS-3001, a CAR-T cell therapy in the treatment of renal cell carcinoma

31 July 2023 - Invectys is pleased to announce the US FDA has granted fast track designation to its revolutionary ...

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Astria Therapeutics receives fast track designation for STAR-0215 for the treatment of hereditary angioedema

20 July 2023 - On track for proof of concept results in HAE patients in mid 2024. ...

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Excision BioTherapeutics receives FDA fast track designation for EBT-101, a first in class CRISPR based gene therapy candidate to functionally cure HIV-1

20 July 2023 - EBT-101 is a potentially curative, one time CRISPR based treatment which makes two cuts in integrated retroviral ...

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FDA grants fast track designation for Ambrx’s ARX517 for the treatment of metastatic castration resistant prostate cancer

19 July 2023 - Ambrx Biopharma today announced that the US FDA has granted fast track designation to Ambrx’s proprietary anti-PSMA ...

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