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Merck Statement on FDA Advisory Committee Meeting for ZINPLAVA ™ (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence
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KENILWORTH, N.J. KENILWORTH, N.J. – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss ZINPLAVA™ (bezlotoxumab), an investigational agen t for prevention of Clostridium difficile ( C. difficile ) infection recurrence. The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the preventi...
Source: Merck.com - Corporate News - June 9, 2016 Category: Pharmaceuticals Tags: Corporate News Latest News Source Type: news
AFP News: AFP Edition.
PMID: 25162159 [PubMed - indexed for MEDLINE]
Source: American Family Physician - June 15, 2014 Category: Primary Care Authors: AFP and AAFP News Staff Tags: Am Fam Physician Source Type: research
Merck ’s KEYTRUDA® (pembrolizumab) Demonstrates Superior Progression-Free and Overall Survival Compared to Chemotherapy as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer
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KENILWORTH, N.J. KEYNOTE-024 Studied Patients Whose Tumors Expressed 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 KEYNOTE-024 trial investigating the use of
KEYTRUDA ® (pembrolizumab), in patients with previously
untreated advanced non-small cell lung cancer (NSCLC) whose tumors
expressed high levels of PD-L1 (tumor proportion score of 50 percent or
more), met its primary endpoint. Language:
English Contact: Merck Media: Pamela Eisele, 26...
Source: Merck.com - Product News - June 16, 2016 Category: Drugs & Pharmacology Tags: Oncology Newsroom Prescription Medicine News Research and Development News Corporate News Latest News #Merck #MRK $MRK cancer Keytruda MSD NYSE:MRK Source Type: news
Merck Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for KEYTRUDA ® (pembrolizumab) in Classical Hodgkin Lymphoma (cHL)
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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 company ’s anti-PD-1 therapy, for the treatment of patients with
relapsed or refractory classical Hodgkin lymphoma (cHL). This is the
fourth Breakthrough Therapy Design...
Source: Merck.com - Product News - April 18, 2016 Category: Drugs & Pharmacology Tags: Oncology Newsroom Prescription Medicine News Corporate News Latest News #Merck #MRK $MRK cancer Hodgkin Lymphoma Keytruda MSD NYSE:MRK Source Type: news
FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab) in Recurrent or Metastatic Head and Neck Cancer, and Grants Priority Review
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
accepted for review the supplemental Biologics License Application
(sBLA) for KEYTRUDA ® (pembrolizumab), the company ’s anti-PD-1
therapy, 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: Merck Media: Pame...
Source: Merck.com - Product News - April 13, 2016 Category: Drugs & Pharmacology Tags: Oncology Newsroom Prescription Medicine News Corporate News Latest News #Merck #MRK $MRK cancer FDA Head and Neck Cancer Keytruda NYSE:MRK Source Type: news
Merck Receives Complete Response Letter from the U.S. FDA for ZETIA ® (ezetimibe) and VYTORIN® (ezetimibe and simvastatin)
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KENILWORTH, N.J. KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter regarding Merck ' s Supplemental New
Drug Applications for ZETIA ® and VYTORIN® for the reduction of the risk
of cardiovascular events (cardiovascular death, nonfatal myocardial
infarction, nonfatal stroke, hospitalization for unstable angina, or
need for revascularization) in patients with coronary heart disease. Language:
English ...
Source: Merck.com - Product News - February 15, 2016 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news
Merck Receives FDA Approval of ZEPATIER ™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review
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KENILWORTH, N.J. ZEPATIER Achieves High Cure Rates (SVR12) in Broad Range of Patients with Chronic Hepatitis C Infection, Including Those with Compensated Cirrhosis, Renal Impairment of Any Degree and HIV-1/HCV Co-infection 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 ZEPATIER ™ (elbasvir and grazoprevir) for the
treatment of adult patients with chronic hepatitis C virus (HCV)
genotype (GT) 1 or GT4 infection, with or witho...
Source: Merck.com - Product News - January 28, 2016 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News #Merck #MRK $MRK Hepatitis NYSE:MRK Source Type: news
Merck ’s KEYTRUDA® (pembrolizumab) Significantly Improves Survival Compared to Chemotherapy in Previously-Treated Patients with Non-Small Cell Lung Cancer Whose Tumors Express Any Level of PD-L1
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KENILWORTH, N.J. KEYNOTE-010 Published in The Lancet and to be Presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced results from the pivotal KEYNOTE-010 study, the first
study of its kind to evaluate the potential of an immunotherapy compared
to chemotherapy based on prospective measurement of PD-L1 expression in
patients with advanced non-small cell lung cancer (NSCLC). Language:
English Contact: Merc...
Source: Merck.com - Product News - December 19, 2015 Category: Drugs & Pharmacology Tags: Oncology Newsroom Prescription Medicine News Corporate News Latest News #Merck #MRK $MRK Keytruda Melanoma MSD pembrolizumab Source Type: news
FDA Approves Expanded Indication for Merck ’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Melanoma
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KENILWORTH, N.J. KEYTRUDA is Now the First and Only Anti-PD-1 Therapy to Achieve Superior Overall Survival Compared to Ipilimumab 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 an expanded indication for KEYTRUDA ® (pembrolizumab),
the company ’s anti-PD-1 (programmed death receptor-1) therapy, to
include the first-line treatment of patients with unresectable or
metastatic melanoma. Language:
English Contact: ...
Source: Merck.com - Product News - December 18, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News #Merck #MRK $MRK Keytruda Melanoma MSD NYSE:MRK Source Type: news
Findings Across a Range of Hematological Cancers Add to The Growing Breadth of KEYTRUDA ® (pembrolizumab) Data
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KENILWORTH, N.J. New Findings Presented at 57th American Society of Hematology Annual Meeting in Difficult-to-Treat Blood Cancers Including Multiple Myeloma and Three Types of Lymphoma Broad KEYTRUDA Development Program in Hematology Includes Four Registrational Studies KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that new study findings investigating the use of KEYTRUDA ®
(pembrolizumab), the company ’s anti-PD-1 therapy, across a range of
hematological cancers were presented at th...
Source: Merck.com - Product News - December 8, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Research and Development News Corporate News Latest News #Merck #MRK $MRK ASH cancer Keytruda NYSE:MRK Source Type: news
Merck Announces Initial Results for KEYTRUDA ® (pembrolizumab) with Novel Immunotherapy Combinations from Three Investigational Studies Presented at the Society for Melanoma Research International Congress
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KENILWORTH, N.J. In Addition, Longer Term Follow-Up Single-Agent Data for KEYTRUDA Shows Continued Superior Overall Response Rate and Progression Free Survival Compared to Ipilimumab KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced findings from three studies investigating the use of
KEYTRUDA ® (pembrolizumab), the company ’s anti-PD-1 therapy,
in combination with three other immunotherapies – epacadostat, IMLYGIC TM
(talimogene laherparepvec), and ipilimumab – in patients with advance...
Source: Merck.com - Product News - November 21, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Research and Development News Corporate News Latest News #Merck #MRK $MRK cancer Keytruda MSD NYSE:MRK Source Type: news
Merck Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for KEYTRUDA ® (pembrolizumab) in Advanced Colorectal Cancer
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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 company ’s anti-PD-1 therapy, for the treatment of
patients with microsatellite instability high (MSI-H) metastatic
colorectal cancer. This is the third Breakthrough Therapy De...
Source: Merck.com - Product News - November 2, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News #cancer #Merck #MRK $MRK colorectal cancer Keytruda MSD NYSE:MRK Source Type: news
Merck ’s KEYTRUDA® (pembrolizumab) Shows Superior Overall Survival Compared to Chemotherapy in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer Whose Tumors Express PD-L1
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KENILWORTH, N.J. Merck Plans Regulatory Submissions in the U.S. in late 2015 and in the European Union in Early 2016 KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced topline results from the KEYNOTE-010 study of KEYTRUDA ®
(pembrolizumab) in advanced non-small-cell lung cancer (NSCLC)
demonstrating that the trial met its primary objective. Language:
English Contact: Merck Media: Pamela Eisele, 267-305-3558 Courtney Ronaldo, 908-236-1108 or Investors: Teri Loxam, 908-740-19...
Source: Merck.com - Product News - October 26, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news
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
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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 company ’s
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 l...
Source: Merck.com - Product News - October 2, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news
MARIZEV ® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan
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 Japanese Pharmaceuticals and Medical Devices
Agency (PMDA) has approved MARIZEV ® (omarigliptin) 25 mg and
12.5 mg tablets, an oral, once-weekly DPP-4 inhibitor indicated for the
treatment of adults with type 2 diabetes. Japan is the first country to
have approved omarigliptin. Language:
English Contact: Media Contacts: Pam Eisele, 267-305-3558 or Michael Close, 310-617-1067 or Kristen Drake, 908-236-4223...
Source: Merck.com - Product News - September 28, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news
