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Protagonist Therapeutics Announces Fast Track Designation Granted by U.S. FDA to Hepcidin Mimetic PTG-300

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ALDX : Aldeyra Therapeutics, Inc. 2018-09-26 07:00:00 Aldeyra Therapeutics Announces Positive Results from Phase 2b Dry Eye Disease Clinical Trial

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AGN : Allergan plc 2018-09-26 07:30:00 Allergan Announces FDA Acceptance of Supplemental New Drug Application For VRAYLAR® (cariprazine)

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CDTX: Cidara Therapeutics, Inc. 2018-09-25 08:00:00 FDA Grants QIDP and Fast Track Designations to Cidara Therapeutics’ Rezafungin Prophylaxis Development Program

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ANAB: AnaptysBio, Inc. 2018-09-24 06:30:00 AnaptysBio Reports Positive Topline Data from Phase 2a Proof-of-Concept Clinical Trial of Etokimab in Severe Eosinophilic Asthma

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IONS: Ionis Pharmaceuticals, Inc. 2018-09-24 07:00:00 Akcea and Ionis Report Positive Data from Phase 2 Study of AKCEA-APO(a)-LRx

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AKCA: Akcea Therapeutics, Inc. 2018-09-24 07:00:00 Akcea and Ionis Report Positive Data from Phase 2 Study of AKCEA-APO(a)-LRx

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BSX: Boston Scientific 2018-09-24 06:45:00 Boston Scientific Receives U.S. FDA Approval for the Eluvia™ Drug-Eluting Vascular Stent System

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IRWD: Ironwood Pharmaceuticals, Inc. 2018-09-13 08:00:00 Ironwood Pharmaceuticals Announces FDA Fast Track Designation for Praliciguat for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)

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ABBV: AbbVie 2018-09-13 06:20:00 AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis

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NMRD: Nemaura Medical Inc. 2018-09-12 08:00:00 Nemaura Reports Positive Interim Data from Clinic Portion of SugarBEAT® FDA Clinical Trial

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ECYT: Endocyte, Inc. 2018-09-10 08:00:00 Endocyte Announces FDA Acceptance of Radiographic Progression Free Survival (rPFS) as an Alternative Primary Endpoint of the VISION Trial in Addition to Overall

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AZN: AstraZeneca 2018-09-07 02:00:00 Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype

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AMGN : Amgen 2018-09-07 02:00:00 Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype

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LOXO: Loxo Oncology, Inc. 2018-09-05 06:45:00 Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292

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PRQR: ProQR Therapeutics N.V. 2018-09-05 04:00:00 ProQR Announces Positive Interim Results from Phase 1/2 Clinical Trial of QR-110 in LCA10 Patients, and Plans to Start a Phase 2/3 Pivotal Trial

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QDEL: Quidel Corporation 2018-08-30 18:40:00 Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia® 2 Lyme Fluorescent Immunoassay for Use with Sofia® 2 Instrument from Finger-Stick Whole Blood Specimens

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INSY: INSYS Therapeutics, Inc. 2018-08-30 06:00:00 FDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Epinephrine Nasal Spray as Investigational Treatment for Anaphylaxis