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U.S. FDA panel: data support safety, efficacy of Merck allergy drug
2014-01-28 23:10:31| Biotech - Topix.net
Merck & Co's experimental allergy drug, Ragwitek, appears safe and effective for use in patients between the ages of 18 and 65, a panel of advisors to the U.S. Food and Drug Administration concluded on Tuesday.
Tags: support
data
safety
panel
Merck Statement on FDA Advisory Committee for Vorapaxar, Merck's Investigational Antiplatelet Medicine
2014-01-16 22:12:41| Biotech - Topix.net
Merck , known as MSD outside the United States and Canada, today said it was pleased with the U.S. Food and Drug Administration 's Cardiovascular and Renal Drugs Advisory Committee's recommendation for approval of vorapaxar.
Tags: statement
medicine
committee
advisory
Merck Statement on FDA Advisory Committee for Vorapaxar, Mercks Investigational Antiplatelet Medicine
2014-01-16 00:59:00| Merck.com - Research & Development 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, today said it was pleased with the U.S. Food and Drug Administration (FDA)s Cardiovascular and Renal Drugs Advisory Committees recommendation for approval of vorapaxar. Vorapaxar is the companys investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orPatrick Witmer, 267-305-4910orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: statement
medicine
committee
advisory
Merck Receives FDA Approval for ISENTRESS (raltegravir) for Pediatric Oral Suspension
2014-01-08 14:30:00| Merck.com - Product 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) recently approved ISENTRESS for oral suspension, a new pediatric formulation of Mercks integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients four weeks of age and older. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orSarra Herzog, 908-423-6154orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: approval
oral
receives
suspension
Merck Wins Over FDA Panel With New Allergy Drug
2013-12-15 12:08:13| Biotech - Topix.net
Merck received word from the U.S. Food & Drug Adminstration that Grastek, an orally administered grass allergy remedy, was both safe and effective for allergy sufferers, according to a report by Reuters .