je.st
news
Tag: nda
Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
2016-08-05 14:00:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Marketing Authorization Application to the European Medicines Agency Currently Under Review KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic1 insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis. Language: English Contact: MerckMedia:Doris Li, 908-246-5701orKristen Drake, 908-236-4223orInvestors:Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
drug
acceptance
filing
NDA selects French firm Areva for R&D in nuclear decommissioning
2016-05-25 01:00:00| Power Technology
UK Nuclear Decommissioning Authority (NDA) has chosen French nuclear power and renewable energy company Areva to be part of its research and development (R&D) framework contract for a Direct Research Portfolio (DRP).
Tags: french
firm
nuclear
selects
NuGen signs land deal with NDA for 10bn nuclear power project in UK
2015-07-16 01:00:00| Power Technology
UK-based nuclear company NuGen has signed a land contract for Moorside site with the Nuclear Decommissioning Authority (NDA) for the proposed 10bn power plant.
Sarepta Therapeutics Completes NDA Submission To FDA For Eteplirsen For The Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping
2015-07-01 08:07:56| drugdiscoveryonline Home Page
Sarepta Therapeutics, Inc., a developer of innovative RNA-targeted therapeutics, recently announced the completion of the rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for eteplirsen on June 26, 2015
Tags: to
treatment
submission
fda
Sarepta Therapeutics Announces Plans To Submit Rolling NDA For Eteplirsen Following Today's Pre-NDA Meeting With The FDA
2015-06-03 06:47:48| drugdiscoveryonline Home Page
Sarepta Therapeutics, Inc., a developer of innovative RNA-targeted therapeutics, recently announced that the Company held a pre-New Drug Application (NDA) meeting with the U.S