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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
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Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet
2016-04-12 23:00:22| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J. 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 Biologics License Application (BLA) for MK-8237, Mercks house dust mite sublingual allergy immunotherapy (SLIT) tablet. Language: English read more
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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
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Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence
2016-01-27 14:30:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. FDA Grants Priority Review with Target Action Date of July 23, 2016 Marketing Authorization Application Also Filed with the European Medicines Agency 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 Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence. The FDA granted Priority Review for bezlotoxumab, with a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Marijuana Regulatory License Application: Security Plan
2015-12-30 16:55:10| PortlandOnline
Marijuana Regulatory License Application: Security Plan PDF Document, 351kbCategory: Marijuana Regulatory License Application Forms
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