je.st
news
Tag: fda
FDA Approves Mercks KEYTRUDA (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy
2016-08-06 01:30:00| 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, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orAn Phan, 908-255-6325orInvestor:Teri Loxam, 908-740-1898orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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
2016-08-05 02:00:00| ThePigSite - Industry News
US - Merck Animal Health (known as MSD Animal Health outside of the United States and Canada) today announced the introduction of Safe-Guard® AquaSol (fenbendazole oral suspension) for use in U.S. swine operations.
Tags: use
health
animal
approval
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
Another FDA Warning Letter
2016-08-02 22:05:20| Happi Breaking News
Sevani Botanica cited for claims.
Tags: letter
warning
fda
fda warning
Sites : [37] [38] [39] [40] [41] [42] [43] [44] [45] [46] [47] [48] [49] [50] [51] [52] [53] [54] [55] [56] next »