WARREN, N.J., Nov. 2, 2018 /PRNewswire/ — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SYMPAZAN™ (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.1 SYMPAZAN is the first and only oral film FDA-approved …
Tag Archives: lennox-gastaut syndrome
November, 2018
June, 2018
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25 June
FDA Approves GW’s Cannabis-Based Drug Epidiolex for the Treatment of Rare, Severe Forms of Epilepsy
London, UK, Carlsbad, CA, June 25, 2018: GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that the U.S. Food and Drug Administration …
April, 2018
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19 April
GW Pharma Wins Unanimous Recommendation from FDA Committee for Approval of its Cannabis-Based Drug
London, UK, Carlsbad, CA, April 19, 2018 – GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced that the Peripheral and Central Nervous System Drugs …
January, 2018
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25 January
GW Pharma Announces Publication of Landmark Epidiolex (cannabidiol) Study in The Lancet
London, UK, Carlsbad, CA, January 24, 2018 – GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that The Lancet has published results from a Phase 3 …
December, 2017
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4 December
Study Evaluates Refractory Epilepsy Screening Tool for Lennox-Gastaut Syndrome
DEERFIELD, Ill.–(BUSINESS WIRE)–Lundbeck today presented data at the American Epilepsy Society (AES) Annual Meeting in Washington, D.C. that demonstrates that the Refractory Epilepsy Screening Tool for LGS (REST-LGS) may help healthcare professionals identify patients who may benefit from further clinical evaluation for Lennox-Gastaut syndrome (LGS). The REST-LGS was developed by …
October, 2016
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28 October
Eisai Initiates Two Phase 3 Trials with Fycompa in Children with Epilepsy
WOODCLIFF LAKE, N.J., Oct. 28, 2016 /PRNewswire/ — Eisai Inc. announced today the initiation of two multi-center, global Phase 3 clinical trials assessing FYCOMPA® (perampanel) CIII in two different patient populations: patients age 2 years and above with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS) (Study 338), a rare …
September, 2016
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26 September
GW Pharma Announces Positive Results from Second Late-Stage Trial Evaluating its Cannabis Drug
London, UK; 26 Sept 2016: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: “GWP,” “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its …
June, 2016
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27 June
GW Pharma’s Epidiolex Succeeds in Late-Stage Lennox-Gastaut Syndrome Study
LONDON, June 27, 2016 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the first randomized, double-blind, placebo-controlled Phase 3 clinical trial of its …
February, 2015
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13 February
FDA Expands Approval of Eisai’s Banzel for Pediatric Patients Ages 1-4
Eisai Inc. announced that US health regulators expanded approval of Banzel (rufinamide) as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients. The company said that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Banzel for treatment of …