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AcelRx Announces FDA Acceptance of NDA for DSUVIA drugs
May 31, 2018
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings
Aerie Pharmaceuticals Submits NDA to FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% drugs
May 17, 2018
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery,
Sage Therapeutics Submits NDA for Intravenous Brexanolone americanpharmaceuticalreview
April 24, 2018
Sage Therapeutics announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
Sage Therapeutics Looks to File NDA for Postpartum Depression Treatment Later This Year biospace
January 15, 2018
Cambridge, Mass.-based SAGE Therapeutics closed out 2017 with stellar results for a mid-stage and late-stage trial aimed at treating two kinds of depression.
5 Biotechs Awaiting FDA Decisions in January 2018 biospace
December 29, 2017
From 1997 through 2013, there was an average of 27 novel drugs approved in the U.S. per year. This year, 46 drugs were approved by the U.S. Food and Drug Administration (FDA)
Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Rela biospace
December 28, 2017
Agios Pharmaceuticals, Inc., a leader in cellular metabolism for the treatment of cancer and rare genetic disorders, today announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA)
Sunovion Announces FDA Acceptance for NDA Review of Dasotraline americanpharmaceuticacreview
November 13, 2017
The NDA submission is supported by multiple placebo-controlled safety and efficacy studies, as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year.
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

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