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Overview of NDA of FDA in Q3: Nearly Half of the 11 New Drugs Possessing “Blockbuster” Potential en-cphi.cn
October 13, 2017
FDA approved 11 new drugs in total (see the attached table for the details) in 2017 Q3. Time is the most objective judge and good things will always stand its tests.
FDA Accepts Supplemental NDA for Lenvatinib as Liver Cancer Treatment americanpharmaceuticacreview
September 28, 2017
There is no guarantee that any investigational uses of such FDA-approved product will gain FDA approval.
Esperion hits goal in LDL trial, pulls forward NDA target date fiercebiotech
August 10, 2017
The data bolster Esperion's hand as it gets deeper into talks about partnerships
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

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