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Mt. Tabor | 9-6-16 | 6012 SE Yamhill St | Historic Landmark Designation Review - NOTICE | LU 16-211301 HL
2016-09-07 20:06:13| PortlandOnline
PDF Document, 736kbCategory: Southeast Uplift Neighborhood Program
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notice
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Mt. Tabor | 9-6-16 | 6012 SE Yamhill St | Historic Landmark Designation Review - NOTICE | LU 16-211301 HL
2016-09-07 17:47:50| PortlandOnline
PDF Document, 736kbCategory: Public Notices
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FDA Accepts Supplemental Biologics License Application, Assigns Priority Review and Grants Breakthrough Therapy Designation to Mercks KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer
2016-09-07 12:45:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Merck Has Also Submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA in the Same Patient Population Submissions Based on Data from KEYNOTE-024 Trial Showing Superior Progression-Free and Overall Survival Compared to Chemotherapy in Patients Whose Tumors Express High Levels of PD-L1 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 Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orCourtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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review
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license
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
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prime
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FDA Grants QIDP And Fast Track Designation To CD101 Topical, Cidara Therapeutics' Novel Antifungal Product Candidate
2016-06-01 05:41:19| drugdiscoveryonline Home Page
Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, recently announced that the U.S. Food and Drug Administration (FDA) has designated the company’s novel antifungal product candidate, CD101 topical, as a Qualified Infectious Disease Product (QIDP), with Fast Track status for its development program
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fast
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