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Dova Pharmaceuticals Announces U.S. FDA Approval of DOPTELET (avatrombopag)

May 22, 2018
Dova Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has completed their Priority Review and approved DOPTELET (avatrombopag) for the treatment of…
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Harmony Biosciences Receives Breakthrough Therapy And Fast Track Designations For Pitolisant

May 22, 2018
Harmony Biosciences announced that it has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the U.S. Food and Drug…
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Thermo Fisher Scientific Installs First Glacios Cryo-Electron Microscope for Drug Discovery and…

May 21, 2018
Thermo Fisher Scientific announced Astex Pharmaceuticals selected the Thermo Scientific Glacios Cryo Transmission Electron Microscope (Cryo-TEM) to aid in its drug discovery and…
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Lokelma approved in the US for the treatment of adults with hyperkalaemia

May 21, 2018
The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalaemia, a serious condition…
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LYRICA (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint

May 18, 2018
Pfizer announced positive top-line results of a Phase 3 study examining the use of LYRICA (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric…
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TEDOR Pharma Announces Recapitalization and New Management

May 18, 2018
TEDOR Pharma announced the closing of a recapitalization and reorganization of its business, funded by investments from DORA Ventures, Inc. DORA Ventures is a newly formed investment…
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Catalent Biologics And Valerius Biopharma To Collaborate On Manufacture Of Specialty Biosimilars

May 18, 2018
Catalent Pharma Solutions and Valerius Biopharma AG announced that they are to collaborate on the development and manufacture of Valerius’ biosimilar products. Under the agreement,…
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Novartis and Amgen announce FDA approval of Aimovig (erenumab-aooe)

May 18, 2018
Novartis announced that the US Food and Drug Administration (FDA) has approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic…
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Amneal Announces FDA Approval and Launch of Generic Welchol (Colesevelam HCl) Tablets, 625 mg

May 17, 2018
Amneal Pharmaceuticals announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol…
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Albireo Enrolls First Patient in Phase 3 PFIC Trial of A4250

May 17, 2018
Albireo Pharma announced the first patient has been enrolled in PEDFIC-1, a Phase 3 clinical trial of lead product candidate A4250, an ileal bile acid transporter (IBAT) inhibitor being…
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