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Merck Statement on FDA Advisory Committee for GRASTEK (Timothy Grass Pollen Allergen Extract), Mercks Investigational Sublingual Allergy Immunotherapy Tablet
2013-12-13 01:17:00| 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, today issued the following statement after the conclusion of the Allergenic Products Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to discuss GRASTEK (Timothy grass pollen allergen extract). Language: English Contact: MerckMedia:Pamela Eisele, 908-423-5042orRobert Consalvo, 908-423-6595orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: statement
committee
advisory
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Merck says FDA won't approve Bridion
2013-09-23 18:36:57| Biotech - Topix.net
Bridion, or sugammadex, is used to reverse the effects of anesthesia after surgery.
Tags: approve
fda
merck
fda merck
Merck Announces FDA Acceptance of New Drug Application for Investigational Fertility Treatment
2013-09-09 14:30:00| 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 announced that the New Drug Application (NDA) for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of corifollitropin alfa for Controlled Ovarian Stimulation (COS) in women participating in assisted reproductive technology. Language: English Contact: MerckMedia:Pam Eisele, 908-423-5042orTina Grasso, 267-893-9783orInvestors:Carol Ferguson, 908-423-4465 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
treatment
drug
acceptance
Exclusive: FDA says working with Merck, USDA on cattle drug Zilmax
2013-08-16 18:55:17| Biotech - Topix.net
The U.S. Food and Drug Administration on Friday said it was working with drugmaker Merck & Co and the U.S. Department of Agriculture to gather information on the cattle feed additive Zilmax and determine if it poses a safety issue.
Tags: working
drug
exclusive
cattle
Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine
2013-07-24 14:00:00| 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 announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack (TIA). About Merck Language: English Contact: MerckMedia:Pamela Eisele, (908) 423-5042orPatrick Witmer, (267) 305-4910orInvestor:Carol Ferguson, (908) 423-4465orJustin Holko, (908) 423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
medicine
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acceptance