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Merck Statement on FDA Advisory Committee Meeting for BRIDION (sugammadex), Investigational Agent for the Reversal of Neuromuscular Blockade (NMB) Induced by Rocuronium or Vecuronium
2015-11-06 20:13:00| 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 issued the following statement after the conclusion of a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss BRIDION (sugammadex). BRIDION is the proposed trade name for Mercks investigational agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Doris Li, 908-740-1903orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck KGaA, Darmstadt, Germany, And Pfizer Announce FDA Orphan Drug Designation For Investigational Immunotherapy Avelumab In Merkel Cell Carcinoma
2015-09-30 08:25:02| drugdiscoveryonline News Articles
Merck KGaA, Darmstadt, Germany, and Pfizer recently announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for the investigational cancer immunotherapy avelumab* for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer
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Merck Announces Submission of Supplemental Biologics License Application (sBLA) to U.S. FDA for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer
2015-04-19 14:00:00| 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 company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). Language: English Contact: Media:Pamela Eisele, 267-305-3558orClaire Mulhearn, 908-236-1118orInvestor:Joseph Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteurs Investigational Pediatric Hexavalent Vaccine
2014-10-20 14:00:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa. Phase III clinical study data presented at IDWeek in Philadelphia WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and NYSE:SNY), announced today that the Biologics License Application (BLA) filed for the companies investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA). Language: English Contact: MerckMedia:Deb Wambold, (215) 652-2913orInvestors:Justin Holko, (908) 423-5088orSanofi PasteurMedia:Susan Watkins, (570) 957-2563susan.watkins@sanofipasteur.comorInvestors:George Grofik, (908) 981-5560IR@sanofi.com Ticker Slug: Ticker: MRK Exchange: NYSE Ticker: SAN Exchange: BOURSE Ticker: SNY Exchange: NYSE read more
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FDA OKs Merck drug for melanoma, 1st in new cancer drug class
2014-09-04 23:14:34| Biotech - Topix.net
Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments.