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Tag: designations
Grazoprevir/Elbasvir, Mercks Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 2015
2015-04-08 13:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. Congress Highlights Include Results from Trials in a Wide Range of HCV Patients -- Patients with Chronic Kidney Disease, HIV Co-infection, Cirrhosis, and Prior Treatment Failures Company Remains on Track for NDA Filing with the U.S. FDA During First Half of 2015 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1879Justin Holko, 908-740-1986 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Where can I find the definition of these designations?
2014-10-03 02:44:32| PortlandOnline
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Definitions of Current and Proposed Designations
2014-10-03 02:41:58| PortlandOnline
Information from the current and proposed Comprehensive Plan documents defining the designations
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FDA grants multiple Orphan Drug Designations for CytRx's aldoxorubicin
2014-09-29 15:24:53| Biotech - Topix.net
CytRx Corporation , a biopharmaceutical research and development company specializing in oncology, today announced that the U.S. Food and Drug Administration has granted multiple Orphan Drug Designations for the Company's lead drug candidate, aldoxorubicin, in three indications: glioblastoma multiforme , small cell lung cancer and ovarian cancer . Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin.
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Mercks Investigational Beta-lactamase Inhibitor Relebactam (MK-7655) Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by FDA
2014-09-04 15:00:00| Merck.com - Corporate News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, 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 designated relebactam (previously known as MK-7655), the companys investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. Language: English Contact: Media:Caroline Lappetito, 267-305-7639orRobert Consalvo, 908-423-6595orInvestors:Joseph Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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