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Seize the Expertise of a FDA Registered Injection Molder for Your Medical Device

2015-10-06 12:31:12| Industrial Newsroom - All News for Today

Any company involved in the production and distribution of medical devices intended for commercial distribution in the United States is required to obtain a registration with the FDA. Most companies who seek to produce medical devices are required to register and to list the devices and the activities performed on...

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USDA, FDA gather input on antimicrobial use and resistance data

2015-10-05 18:12:00| National Hog Farmer

By P. Scott Shearer, Bockorny Group, Washington, D.C. USDA and FDAs Centers for Disease Control and Prevention gathering input to assess impact of measures being implemented to foster the judicious use of medically important antimicrobial drugs for livestock. read more

Tags: data input resistance gather

FDA Expands Approval Of Merck's Keytruda To Lung Cancer

2015-10-04 19:17:21| Biotech - Topix.net

The U.S. Food and Drug Administration on Friday approved Merck & Co Inc's immunotherapy, Keytruda, for patients with the most common form of lung cancer whose tumors produce a specific biological marker. The FDA approval for Keytruda in advanced non-small cell lung cancer is for patients whose tumors express PD-L1, a protein targeted by the drug, and includes a companion diagnostic, made by a unit of Agilent Technologies Inc, to measure those protein levels.

Tags: approval cancer lung expands

FDA Approves KEYTRUDA (pembrolizumab) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 with Disease Progression On or After Platinum-Containing Chemotherapy

2015-10-02 20:49:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. Patients with EGFR or ALK Genomic Tumor Aberrations Should Have Disease Progression on FDA-Approved Therapy for These Aberrations Prior to Receiving KEYTRUDA 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) monotherapy, the companys anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Language: English Contact: MerckMedia Contacts:Pamela Eisele, 267-305-3558Courtney Ronaldo, 908-236-1108orInvestor Contacts:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: or express cell treatment