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Tag: license application
FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, for First-Line Treatment of Advanced Melanoma, and Grants Priority Review
2015-08-18 14:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Merck Provides Additional Update: FDA Extends Action Date for Additional sBLA in Ipilimumab-Refractory Advanced Melanoma KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orInvestors:Justin Holko, 908-740-1879An Phan, 908-255-6325 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
review
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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Advanced Non-Small Cell Lung Cancer, and Grants Priority Review
2015-06-01 22:34:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KEYNOTE-001 Data Served as the Basis for U.S. FDA Filing and Breakthrough Therapy Designation in Advanced NSCLC Across Histologies 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 accepted for review the supplemental Biologics License Application (sBLA) for Mercks anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. Language: English Contact: MerckMedia:Pamela Eisele, 267-664-0282Claire Mulhearn, 908-200-1889orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
review
application
license
Merck Announces Submission of Supplemental Biologics License Application (sBLA) to U.S. FDA for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer
2015-04-19 14:00:00| 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 company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). Language: English Contact: Media:Pamela Eisele, 267-305-3558orClaire Mulhearn, 908-236-1118orInvestor:Joseph Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
application
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cell
Spider9 to license OSE technology to Samsung Electronics; enables first application beyond the stationary energy storage market
2015-01-08 18:55:37| Green Car Congress
Tags: technology
market
application
electronics
Utility License Application
2014-11-03 18:36:47| PortlandOnline
All lines must be completed for an application to be processed PDF Document, 73kbCategory: Licenses
Tags: application
license
utility
license application