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FDA has safety concerns with Merck insomnia drug
2013-05-20 21:15:54| Biotech - Topix.net
The Food and Drug Administration on Monday released its review of the company's sleep aid, suvorexant, ahead of a public meeting on Wednesday.
Tags: safety
drug
concerns
fda
FDA reviewing Merck ragweed allergy therapy
2013-05-08 19:42:40| Biotech - Topix.net
Drugmaker Merck & Co. says the Food and Drug Administration is reviewing its second application to sell a new type of allergy treatment meant to gradually reduce allergic reactions over time, rather than just relieving sneezing, itching and other symptoms temporarily.
Tags: therapy
reviewing
allergy
fda
Merck Announces FDA Acceptance of Biologics License Application for Investigational Ragweed Pollen Sublingual Allergy Immunotherapy Tablet
2013-05-08 14:30:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet has been accepted for review by the U.S. Food and Drug Administration (FDA). On March 27, Merck announced that the FDA had also accepted the BLA for its investigational Timothy grass pollen (Phleum pratense) sublingual allergy immunotherapy tablet. Language: English Contact HTML: MerckMedia:Pam Eisele, 908-423-5042Robert Consalvo, 908-423-6595orInvestor:Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
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Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL (posaconazole)
2013-04-10 14:30:00| Merck.com - Product News
Dateline City: WHITEHOUSE STATION N.J. WHITEHOUSE STATION N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA). Language: English Contact HTML: MerckMedia:Pam Eisele, (908) 423-5042Robert Consalvo, (908) 423-6595orInvestor:Carol Ferguson, (908) 423-4465Justin Holko, (908) 423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck: FDA Reviewing Tablet to Eliminate Allergy
2013-03-28 17:38:48| Biotech - Topix.net
Drugmaker Merck & Co. said Wednesday that federal regulators are reviewing its application to sell a new type of treatment for grass pollen allergy that gradually reduces allergy symptoms over time, rather than just temporarily relieving the sneezing and itching.
Tags: eliminate
reviewing
tablet
allergy