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Merck Receives FDA Acceptance of Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
2017-01-10 22:06:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Submission Based on Data from KEYNOTE-021 Trial, Cohort G, Which Enrolled Patients Regardless of PD-L1 Expression KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orCourtney Ronaldo, 908-236-1108orInvestor:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE @Merck read more
Tags: application
license
cell
treatment
Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
2016-08-05 14:00:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Marketing Authorization Application to the European Medicines Agency Currently Under Review KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic1 insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis. Language: English Contact: MerckMedia:Doris Li, 908-246-5701orKristen Drake, 908-236-4223orInvestors:Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
drug
acceptance
filing
Merck Animal Health receives FDA approval of Safe-Guard AquaSol for use in swine
2016-08-04 06:00:00| National Hog Farmer
Merck Animal Health today announced the introduction of Safe-Guard AquaSol (fenbendazole oral suspension) for use in U.S. swine operations. Safe-Guard AquaSol is indicated for the treatment and control of adult and larval stages of large roundworms, whipworms and kidney worms, as well as adult stages of the small stomach worm, nodular worm and lungworm. read more
Tags: use
health
animal
approval
Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)
2016-07-25 14:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced two regulatory milestones for the companys investigational vaccine for Ebola Zaire, V920 (rVSVG-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) status. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Skip Irvine, 215-652-6059orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: status
prime
therapy
receives
Merck Animal Health Receives FDA Approval of BRAVECTO (fluralaner topical solution) for Cats and Dogs
2016-07-21 23:00:00| Merck.com - Corporate News
Dateline City: MADISON, N.J. Topical Treatment for Fleas and Ticks Effective for up to 12 Weeks MADISON, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, today announced the U.S. Food and Drug Administrations approval of BRAVECTO (fluralaner topical solution) for both cats and dogs, a topical treatment for fleas and ticks effective for up to 12 weeks1,2 following a single dose. Language: English Contact: Merck Animal HealthMedia:Kelly Goss, 913-558-6452 kelly.goss@merck.com orPamela Eisele, 267-305-3558 pamela.eisele@merck.com orInvestor Relations:Amy Klug, 908-740-1898 amy.klug@merck.com Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: health
solution
animal
approval