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Merck Statement on FDA Advisory Committee Meeting for ZINPLAVA (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence
2016-06-09 23:04:32| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss ZINPLAVA (bezlotoxumab), an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the prevention of C. Language: English read more
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Merck Announces FDA Accepts Samsung Bioepis Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade
2016-05-24 01:50:08| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. First BLA Filed by Samsung Bioepis as Part of Its Partnership with Merck KENILWORTH, N.J. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. Language: English read more
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Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet
2016-04-12 23:00:22| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-8237, Mercks house dust mite sublingual allergy immunotherapy (SLIT) tablet. Language: English read more
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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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FDA OKs Merck hepatitis C drug, adding to patient choices
2016-01-29 02:48:54| Biotech - Topix.net
Patients with hepatitis C have yet another advanced treatment option, as the Food and Drug Administration on Thursday approved a new once-a-day pill developed by drugmaker Merck. The FDA said Merck can begin marketing Zepatier for patients with two of the subtypes the liver-destroying virus, types 1 and 4. The combination pill includes the medications elbasvir and grazoprevir, which attack the virus in two different ways.
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