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Tag: drug administration
Merck Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for KEYTRUDA (pembrolizumab) in Classical Hodgkin Lymphoma (cHL)
2016-04-18 14:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Fourth Designation for KEYTRUDA Follows Breakthrough Status in Advanced Melanoma, Non-Small Cell Lung Cancer, and Colorectal Cancer 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 granted Breakthrough Therapy Designation to KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This is the fourth Breakthrough Therapy Designation granted for KEYTRUDA. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558An Phan, 908-255-6325orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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administration
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drug
Merck Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for KEYTRUDA (pembrolizumab) in Advanced Colorectal Cancer
2015-11-02 14:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Designation Based on Results in Patients with Metastatic Colorectal Cancer with High Levels of Microsatellite Instability 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 granted Breakthrough Therapy Designation to KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. This is the third Breakthrough Therapy Designation granted for KEYTRUDA. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orKim Hamilton, 908-740-1863orInvestor:Teri Loxam, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
food
administration
drug
Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection
2015-07-28 12:30:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Company Granted FDA Priority Review with Target Action Date of January 28, 2016 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:Doris Li, (908) 246-5701Sarra Herzog, (201) 669-6570orInvestor:Joe Romanelli, (908) 740-1986Justin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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food
application
administration
Arcadia Biosciences' Nitrogen Use Efficiency Trait Completes US Food And Drug Administration Early Food Safety Evaluation
2015-06-17 05:26:49| foodingredientsonline Home Page
Arcadia Biosciences, Inc., an agricultural technology company, announced recently that the US Food and Drug Administration (FDA) has completed the Early Food Safety Evaluation (EFSE) process for the plant protein responsible for the companys Nitrogen Use Efficiency (NUE) trait
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early
safety
administration
Alnylam Receives Orphan Drug Designation From The United States Food & Drug Administration For Revusiran, An Investigational RNAi Therapeutic For The Treatment Of Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)
2015-06-03 06:41:56| drugdiscoveryonline Home Page
Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced recently that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to revusiran, an investigational RNAi therapeutic, for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis)
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united states
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