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Spring Supplemental CBO Review

2016-04-14 00:01:09| PortlandOnline

CBO analyst reviews - combined PDF Document, 635kbCategory: FY 2015-16 Spring BMP

FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Recurrent or Metastatic Head and Neck Cancer, and Grants Priority Review

2016-04-13 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 recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. 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

Tags: review application head license

FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer

2016-03-07 14:00:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. Application Based on Data from KEYNOTE-010, Which Showed Superior Overall Survival for Patients Taking KEYTRUDA Compared to Chemotherapy in Patients with PD-L1 Expression on One Percent or More of the Cancer Cells 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 a new supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, to include data from KEYNOTE-010. 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 application license cell