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A Technique for Preventing Recurrence

2018-08-07 18:27:35| Electrical Construction & Maintenance

When failures recur, you need to find a different way of defining success

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FDA Approves Mercks ZINPLAVA (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence

2016-10-22 03:57:00| 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 announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA (bezlotoxumab) Injection 25 mg/mL. Merck anticipates making ZINPLAVA available in first quarter 2017. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Merck Statement on FDA Advisory Committee Meeting for ZINPLAVA (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence

2016-06-09 23:04:32| 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 issued the following statement after the conclusion of a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss ZINPLAVA (bezlotoxumab), an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the prevention of C. Language: English read more

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Longer night fasting tied to reduced breast cancer recurrence

2016-04-01 00:57:36| Biotech - Topix.net

For breast cancer survivors, the risk of recurrence may be tied to how many hours they fast at night, a new study suggests. Women in the study were more likely to have their breast cancer come back if they fasted overnight for less than 13 hours, researchers found.

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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

Tags: application license acceptance prevention

 

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