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Metro's Response Letter
2018-04-30 18:59:50| PortlandOnline
PDF Document, 1,439kbCategory: April
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Newron Receives Complete Response Letter From US FDA For Xadago (safinamide)
2016-03-30 07:24:45| drugdiscoveryonline Home Page
Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, and its partners Zambon S.p.A. and US WorldMeds announced recently that a complete response letter from the FDA has been received for safinamide
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Merck Receives Complete Response Letter from the U.S. FDA for ZETIA (ezetimibe) and VYTORIN (ezetimibe and simvastatin)
2016-02-15 23:30:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for ZETIA and VYTORIN for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orMichael Close, 267-305-1211orInvestors:Amy Klug, 908-740-1898orTeri Loxam, 908-740-1986 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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CP Sends Response to Letter to STB Illinois Delegation Related to Potential Norfolk Deal
2015-12-18 13:56:20| Railroads - Topix.net
I am writing in response to your letter dated December 14th to the Surface Transportation Board expressing concerns about a possible combination between Canadian Pacific and Norfolk Southern . I was surprised to read this letter in the media as it would have been my pleasure to sit down with you and walk through the benefits of our proposal to Illinois and Chicago and to address concerns.
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Genzyme Receives Complete Response Letter from FDA on Lemtradaa (alemtuzumab) Application
2013-12-30 08:58:17| Biotech - Topix.net
Genzyme , a Sanofi company , announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its supplemental Biologics License Application seeking approval of Lemtrada for the treatment of relapsing forms of multiple sclerosis.
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