Home license application
 

Keywords :   


Tag: license application

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

 

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

Tags: house application license acceptance

 
 

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

 

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

Tags: application license acceptance prevention

 

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

Tags: plan security application license

 

Sites : [1] [2] [3] [4] [5] [6] [7] next »