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Tag: investigational
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
Mercks Investigational Once-Daily Formulation of ISENTRESS (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study
2016-02-22 14:00:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Results to be Presented at Future Medical Meeting, and Regulatory Submissions Planned for 2016 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced top-line results from the companys Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults. Language: English Contact: For MerckMedia:Pamela Eisele, 267-305-3558orCarmen de Gourville, 267-305-4195orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: study
primary
phase
secondary
Sangamo Announces FDA Clearance Of Investigational New Drug Application
2016-02-09 03:38:16| drugdiscoveryonline News Articles
Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for SB-318, a single treatment strategy intended to provide a life-long therapy for Mucopolysaccharidosis Type I (MPS I).
Tags: application
drug
clearance
announces
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
World Health Organization to Review Mercks Investigational Ebola Vaccine for Emergency Use Assessment and Listing
2015-12-23 14:30:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the application for Emergency Use Assessment and Listing (EUAL) for the companys investigational Ebola Zaire vaccine, V920 (rVSVG-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization (WHO). Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Skip Irvine, 215-652-6059orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: world
health
review
listing
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