BlueRock Therapeutics receives FDA fast track designation for OpCT-001 for the treatment of primary photoreceptor diseases

27 February 2025 - First iPSC-derived investigational cell therapy, OpCT-001, to be clinically tested for treating primary photoreceptor diseases. ...

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Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer

26 February 2025 - Pyxis Oncology today announced that the US FDA has granted fast track designation to PYX-201 for the ...

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US FDA grants fast track designation to Coherent Biopharma’s CBP-1019

21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...

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Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia

24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...

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World’s first potential target therapy for diffuse gastric cancer granted fast track designation by the US FDA

20 February 2025 - Signet Therapeutics announced that the US FDA has granted fast track designation for SIGX1094, the world's first ...

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Doron Therapeutics receives FDA regenerative medicine advanced therapy designation for Motys for treatment of symptoms associated with osteoarthritis

19 February 2025 - Doron Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...

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Fast track granted by FDA for NNZ-2591 in Pitt Hopkins syndrome

19 February 2025 - : Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 ...

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Rznomics liver cancer drug candidate secures fast track designation

17 February 2025 - Second fast track designation following brain cancer approval. ...

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Innovent receives second fast track designation from the US FDA for IBI363 (PD-1/IL-2α-bias bipspecific antibody fusion protein) in squamous non-small cell lung cancer

17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...

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FDA grants fast track designation to PleoPharma's investigational new drug PP-01 for the mitigation of cannabis withdrawal symptoms in patients with cannabis use disorder: a potential first in class treatment

13 February 2025 - Phase 3 preparations underway. ...

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NKGen Biotech receives US FDA fast track designation for troculeucel for the treatment of moderate Alzheimer’s disease

12 February 2025 - NKGen Biotech today announced that the US FDA has granted fast track designation for the investigation of ...

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Lundbeck’s potential treatment amlenetug for multiple system atrophy receives fast track designation from the FDA

12 February 2025 - Lundbeck today announced that amlenetug has received fast track designation from the US FDA. ...

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OnCusp Therapeutics receives FDA fast track designation for CUSP06 for the treatment of platinum-resistant ovarian cancer

12 February 2025 - OnCusp Therapeutics today announced that the US FDA has granted fast track designation to CUSP06, a cadherin-6 ...

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Biodexa receives US FDA fast track designation for eRapa in familial adenomatous polyposis

10 February 2025 - Biodexa Pharmaceuticals announced today that the US FDA has granted fast track designation for eRapa, a proprietary ...

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Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate to severe atopic dermatitis

10 February 2025 - Nektar Therapeutics today announced that the US FDA has granted fast track designation for rezpegaldesleukin for the ...

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