Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations

21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...

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FDA grants Purdue Pharma’s nalmefene hydrochloride injection fast track designation for the emergency treatment of known or suspected opioid overdose

13 March 2019 - Committed to advancing solutions to the opioid public health crisis, Purdue will not profit from nalmefene hydrochloride. ...

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Iovance Biotherapeutics was granted fast track designation for LN-145 for cervical cancer

26 February 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted fast track designation for LN-145 for the ...

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Themis Bioscience receives FDA fast track designation for Chikungunya vaccine candidate

25 February 2019 - Themis Bioscience announced today that the United States FDA has granted fast track designation to the ...

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Cerecor receives fast track designation from FDA for CERC-801 for the treatment of PGM1 deficiency

19 February 2019 - Cerecor announced today that the U.S. FDA has designated fast track designation for CERC-801, an ultra-pure, oral ...

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Neurelis announces that Intravail licensee ARS Pharmaceuticals intranasal epinephrine program given fast track designation

20 February 2019 - ARS Pharmaceuticals announced that ARS-1, an intranasal epinephrine spray in development to treat severe allergic reactions, was ...

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OncoGenex announces fast track designation granted for custirsen in combination with cabazitaxel/prednisone as second-line chemotherapy in Phase 3 AFFINITY trial of men with metastatic castrate-resistant prostate cancer

 23 April 2014 - Third Phase 3 trial of custirsen to receive FDA fast track designation. ...

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Tokai Pharmaceuticals’ galeterone receives fast track designation from the FDA for the treatment of advanced prostate cancer

12 June 2012 - Tokai Pharmaceuticals today announced that its lead candidate, galeterone (TOK-001), has received fast track designation from ...

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Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint

24 October 2018 - Bayer has been granted fast track designation by the U.S. FDA for darolutamide in men with nmCRPC. ...

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Innocrin Pharmaceuticals granted fast track designation by FDA for VT-464 treatment of patients with metastatic castrate-resistant prostate cancer

6 January 2016 - Seviteronel to be presented in three sessions at the ASCO Genitourinary Cancer Symposium to be held in ...

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RDD Pharma receives fast track designation from FDA for RDD-0315 for treatment of faecal incontinence in spinal cord injury patients

14 February 2019 - RDD Pharma announced today that the U.S. FDA granted fast track status for RDD-0315 for the treatment ...

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Neurotech Pharmaceuticals granted fast track designation from the U.S. FDA for the treatment of macular telangiectasia type 2

12 February 2019 - Neurotech Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company's development ...

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Apellis Pharmaceuticals’ APL-2 receives fast track designation from the FDA for the treatment of patients with paroxysmal nocturnal haemoglobinuria

11 February 2019 - New designation now includes all PNH patients. ...

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Pharnext announces FDA fast track designation for Pleodrug PXT3003 for the treatment of Charcot-Marie-Tooth disease type 1A

4 February 2019 - Pharnext announced today that the U.S. FDA has granted fast track designation for the development of PXT3003 ...

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Innate Pharma receives FDA fast track designation for IPH4102 in relapsed or refractory Sézary syndrome

29 January 2019 - Fast track designation is based on the evaluation of Phase I results demonstrating strong clinical activity, favourable ...

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