Applied Therapeutics granted fast track designation by FDA for AT-007 for galactosaemia

17 June 2021 - Applied Therapeutics today announced that the U.S. FDA has granted fast track designation to AT-007 for the ...

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Cerevel Therapeutics announces fast track designation granted by the U.S. FDA to CVL-871 for the treatment of dementia related apathy

15 June 2021 - Cerevel Therapeutics announced that the U.S. FDA has granted fast track designation to CVL-871, a D1/D5 ...

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Istari Oncology announces FDA granted fast track designation to PVSRIPO for the treatment of advanced melanoma

14 June 2021 - Istari Oncology announced today the U.S. FDA has granted fast track designation to PVSRIPO for the ...

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VBI Vaccines granted FDA fast track designation for VBI-1901 for the treatment of recurrent GBM

8 June 2021 - Designation granted based on data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients. ...

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BerGenBio receives FDA fast track designation for bemcentinib/anti-PD-(L)1 combination in NSCLC

8 June 2021 - First recognition by a regulator of AXL positive patients as a target population. ...

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Boehringer Ingelheim and Zealand Pharma receive FDA fast track designation for investigational treatment for NASH

2 June 2021 - FDA’s fast track designation for the GLP-1/glucagon dual agonist underscores the urgent need for new treatment options ...

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BridgeBio Pharma receives FDA fast track designation for encaleret for the treatment of autosomal dominant hypocalcaemia type 1

1 June 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation for encaleret for the treatment ...

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Novartis receives FDA fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes

25 May 2021 - Novartis today announced that the US FDA has granted fast track designation for sabatolimab (MBG453) for the ...

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Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA

25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...

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Scholar Rock receives fast track designation from the U.S. FDA for apitegromab for the treatment of patients with spinal muscular atrophy

24 May 2021 - Builds on Priority Medicines (PRIME) designation recently granted by the EMA recognising the unmet medical needs of ...

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AffyImmune Therapeutics' AIC100 granted fast track designation for treating thyroid cancer

17 May 2021 - AffyImmune Therapeutics announced today that the US FDA granted fast track designation to its lead compound, AIC100, ...

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BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia

14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...

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Palisade Bio receives FDA fast track designation for LB1148 for reduction of adhesions following abdominal and pelvic surgery

13 May 2021 - LB1148 was previously granted fast track designation from the U.S. FDA for the treatment of post-operative GI ...

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Fulcrum Therapeutics announces U.S. FDA grants fast track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy

12 May 2021 - Fulcrum Therapeutics today announced that the U.S. FDA has granted fast track designation to losmapimod for ...

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Evofem Biosciences receives fast track designation for EVO100 for prevention of gonorrhoea in women

12 May 2021 - Potential for expedited NDA review of EVO100 by FDA. ...

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