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GSK files supplementary NDA for asthma treatment arnuity ellipta pharmaceutical-technology
July 27, 2017
GSK has submitted a supplementary New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of arnuity ellipta (fluticasone furoate) as a maintenance treatment of children with asthma.
NDA of FDA in 2017 Q2: Total Number of New Drugs Approved Having Surpassed That of the 2016 en-cphi.cn
July 07, 2017
With a half of 2017 past, unlike the downturn experienced in 2016, the new drug approval of FDA in 2017 can be called sailing with the wind...
Midazolam Nasal Spray Phase 3 Trial Meets Primary Efficacy Endpoint americanpharmaceuticalreview
April 28, 2017
Proximagen Limited announced its Phase 3 trial of intranasal midazolam (USL261) for the rescue treatment of seizure clusters, met its primary efficacy endpoint in a top-level analysis of the data.
GSK and Daiichi Sankyo JV submits NDA for candidate shingles vaccine in Japan pharmaceutical-technology
April 21, 2017
GlaxoSmithKline (GSK) and Daiichi Sankyo joint venture (JV) Japan Vaccine Co has submitted a New Drug ...
Aeterna Zentaris Intends to File NDA with Respect to Macrilen in Third Quarter of 2017 drugs.com
April 06, 2017
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the “Company”) today announced that, following its meeting with the U.S. Food and Drug Administration (the “FDA” or the “Agency”) on March 29, 2017.
Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an I drugs.com
April 06, 2017
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced the completion on March 31, 2017 of a rolling submission of a New Drug Application (NDA)...
AbbVie granted priority review in Japan for its investigational regimen of Glecaprevir/Pibrentasvir pharmaasia
March 27, 2017
AbbVie to prioritize review in Japan for its investigational regimen of Glecaprevir/Pibrentasvir for the treatment of major genotypes of chronic Hepatitis C
Nicox Resubmits AC-170 (Zerviate) NDA to the U.S. FDA drugs.com
March 13, 2017
Nicox S.A. announced the resubmission of the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.
PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna for the drugs.com
March 07, 2017
PTC Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the filing over protest of PTC's New Drug Application (NDA)...

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