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Alkermes, Biogen Submits NDA for Diroximel Fumarate americanpharmaceuticalreview
December 18, 2018
Alkermes and Biogen announced Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098).....
FDA Grants Priority Review for Daiichi Sankyo's NDA for FLT3 Inhibitor Quizartinib americanpharmaceuticalreview
November 29, 2018
Daiichi Sankyo announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment....
Adamis Pharmaceuticals Adds Sublingual Erectile Dysfunction Product Candidate to its Pipeline pharmafocusasia
November 28, 2018
Adamis Pharmaceuticals Corporation announced today that it has been conducting pre-IND development work for a fast-dissolving sublingual tablet containing tadalafil......
Proprietary Nasal Delivery Formulation of Diazepam Developed by Particle Sciences Reaches NDA contractpharma
November 12, 2018
Proprietary Nasal Delivery Formulation of Diazepam Developed by Particle Sciences Reaches NDA
FDA Extends Inbrija NDA Review Period americanpharmaceuticalreview
September 18, 2018
Acorda Therapeutics announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date...
ViiV submits two-drug regimen for HIV in Europe pharmatimes
September 18, 2018
ViiV Healthcare has submitted an application in Europe for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine...
FDA Issues Complete Response Letter for NDA for Dasotraline americanpharmaceuticalreview
September 03, 2018
Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatme
Shionogi submits NDA for INTUNIV biospectrumasia
August 22, 2018
Shire’s partner, Shionogi, filed application to expand INTUNIV indication in Japan to include adults with ADHD.
Shire submits NDA in Japan for Intuniv to treat ADHD drugs
August 15, 2018
Irish biotechnology company Shire, through its partner Shionogi, has filed a new drug application (NDA) in Japan seeking approval to manufacture and market its Intuniv medicine for the treatment of adults with attention deficit hyperactivity disorder (ADH
Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza americanpharmaceuticalreview
July 24, 2018
Ocular Therapeutix has received acknowledgement from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for Dextenza has been received.

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