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FDA Approves Mercks Single-Dose EMEND (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (MEC)

2016-02-04 14:00:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. First and Only Intravenous NK1 Receptor Antagonist Approved in the U.S. for Use in MEC 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 a supplemental new drug application (sNDA) for single-dose EMEND (fosaprepitant dimeglumine) for injection, Mercks substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). 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

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FDA Approves Expanded Indication for Mercks KEYTRUDA (pembrolizumab) for the Treatment of Patients with Advanced Melanoma

2015-12-18 22:05:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KEYTRUDA is Now the First and Only Anti-PD-1 Therapy to Achieve Superior Overall Survival Compared to Ipilimumab 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 an expanded indication for KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. Language: English Contact: MerckMedia Contacts:Pamela Eisele, 267-305-3558orAn Phan, 908-255-6325orInvestor Contacts:Teri Loxam, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: with advanced treatment expanded

 
 

FDA approves cheaper version of Sanofi's bestselling insulin; it's from Eli Lilly, Boehringer

2015-12-17 01:17:36| Biotech - Topix.net

Federal health officials have approved a cheaper version of the world's top-selling insulin from Sanofi for millions of U.S. patients with diabetes. The Food and Drug Administration approved a new form of Sanofi's pen-like injector, Lantus, from drugmakers Eli Lilly and Co.

Tags: version cheaper eli bestselling

 

FDA Approves Expanded Age Indication for GARDASIL 9 in Males

2015-12-15 23:07:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. GARDASIL 9 Now Approved for Males 16 through 26 Years of Age for the Prevention of Anal Cancers and Genital Warts Caused by Nine HPV types KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orDeb Wambold, 215-652-2913orInvestors:Teri Loxam, 908-740-1986orJustin Holko, 908-740-1879 Media Capsule: Please Activate Javascript !function(d, s, id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https',dt=new Date().getTime();if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+"://s3.amazonaws.com/contentcapsule.com/clients/Merck/tags/4ef0f659-dc5f-471f-a926-02d1aa18adfe_reg_frame.js?dt="+dt;fjs.parentNode.insertBefore(js,fjs);}}(document,"script","contentcapsule-embed-4ef0f659-dc5f-471f-a926-02d1aa18adfe"); read more

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FDA approves Genentech drug for advanced lung cancer

2015-12-11 23:03:49| Biotech - Topix.net

The Food and Drug Administration on Friday conditionally approved an experimental Genentech drug for patients with a certain type of lung cancer who have few other options. Alecensa won accelerated approval for patients with advanced non-small cell lung cancer with a mutation in a gene called ALK who have relapsed after treatment with Pfizer Inc.'s Xalkori or who could not tolerate that drug.

Tags: advanced drug cancer lung

 

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