Home Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
 

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Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab

2016-07-21 22:30:00| 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, today said that the U.S. Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. 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 update agent regulatory

Category:Biotechnology and Pharmaceuticals

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