NRx Pharmaceuticals announces FDA qualified infectious disease product and fast track designation of NRX-101 in complicated urinary tract infection and pyelonephritis

16 January 2024 - QIDP designation grants priority review and an additional 5 years of additional product exclusivity. ...

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RemeGen's RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients

12 January 2024 - RemeGen announced recently that its independently developed mesothelin targeting antibody drug conjugate RC88 has been granted fast ...

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Seres Therapeutics announces US FDA fast track designation for SER-155

9 January 2024 - SER-155 Phase 1b placebo controlled Cohort 2 data readout anticipated in third quarter of 2024. ...

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Sellas Life Sciences receives FDA fast track designation for SLS009 for treatment of relapsed/refractory acute myeloid leukaemia

9 January 2024 - Sellas Life Sciences Group today announced that the US FDA has granted fast track designation to SLS009 ...

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Cabaletta Bio receives additional FDA fast track designations for CABA-201 in dermatomyositis and systemic sclerosis

8 January 2024 - Second and third FDA fast track designations for CABA-201, following the systemic lupus erythematosus and lupus ...

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FDA grants Soligenix fast track designation for dusquetide in the treatment of oral lesions of Behçet's disease

8 January 2024 - Soligenix announced today that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's ...

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ProfoundBio announces rinatabart sesutecan FDA fast track designation for patients with advanced ovarian cancer

5 January 2023 - ProfoundBio today announced that the US FDA has granted fast track designation for rinatabart sesutecan (Rina-S; ...

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Imaging Biometrics granted FDA fast track

19 December 2023 - Imaging Biometrics is pleased to announce that the US FDA has granted fast track designation for oral ...

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FDA grants fast track designation to Henlius’ EGFR targeting ADC HLX42 for NSCLC patients with disease progression on EGFR targeted therapies

27 December 2023 - Shanghai Henlius Biotech announced that the US FDA granted fast track designation for HLX42, an investigational EGFR ...

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Lexeo Therapeutics granted FDA fast track designation and orphan drug designation for LX2020, an AAV based gene therapy candidate for PKP2 arrhythmogenic cardiomyopathy

18 December 2023 - Lexeo Therapeutics today announced the US FDA has granted fast track designation and orphan drug designation to ...

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Abbisko Therapeutics announces that US FDA has granted fast track designation for its CSF-1R inhibitor pimicotinib (ABSK021)

13 December 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ...

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Kyverna Therapeutics granted FDA fast track designation for KYV-101 in the treatment of patients with refractory myasthenia gravis

13 December 2023 - KYV-101 is a fully human CD19 CAR T-cell therapy designed for use in patients with B ...

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Candel Therapeutics receives FDA fast track designation for CAN-2409 in pancreatic cancer

12 December 2023 - Candel Therapeutics today announced that the US FDA granted fast track designation for its lead investigational adenovirus ...

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Erasca granted FDA fast track designation for pan-RAF inhibitor naporafenib in patients with advanced NRAS mutated melanoma

11 December 2023 - First in class and best-in-class potential in NRAS mutated melanoma and other RAS/MAPK pathway altered solid tumours. ...

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EnGeneIC granted FDA fast track designation for novel armed nanocell drug conjugate pancreatic cancer therapeutic

7 December 2023 -  EnGeneIC has achieved a significant milestone with the granting of FDA fast track designation for its ...

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