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Merck Receives FDA Acceptance of Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
2017-01-10 22:06:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Submission Based on Data from KEYNOTE-021 Trial, Cohort G, Which Enrolled Patients Regardless of PD-L1 Expression 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:Pamela Eisele, 267-305-3558orCourtney Ronaldo, 908-236-1108orInvestor:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE @Merck read more
Tags: application
license
cell
treatment
FDA Posting Adverse Event Report Data for Cosmetics and Food
2016-12-06 21:30:00| Happi Breaking News
Data to be posted quarterly.
FDA Warning Letter Exposes Violations at Skin Care Firm
2016-12-01 21:47:00| Happi Breaking News
FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for Mercks KEYTRUDA (pembrolizumab) in Relapsed or Refractory Classical Hodgkin Lymphoma
2016-12-01 13:00:00| 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 U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orKim Hamilton, 908-740-1863orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: review
application
license
classical
FDA Grants Priority Review to Mercks Supplemental Biologics License Application (sBLA) Seeking Approval for KEYTRUDA (pembrolizumab) for New Indication in Microsatellite Instability-High Cancer
2016-11-28 13:00:00| 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 U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orKim Hamilton, 908-740-1863orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: review
application
license
approval
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