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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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Gilead Sciences, Inc. Pushes for FDA Blockbuster Approval

2013-04-09 20:51:54| Biotech - Topix.net

April 09, 2013 -- Gilead Sciences today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of sofosbuvir a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus infection.

Tags: sciences approval fda pushes

 
 

FDA Plans Public Meeting on Cosmetic Regulation

2013-04-09 16:38:37| Happi Breaking News

May 8 event to prep for upcoming ICCR-7 Meeting

Tags: public plans meeting regulation

 

FDA Plans Public Meeting on Cosmetic Regulation

2013-04-08 17:38:00| Happi Breaking News

May 8 event to prep for upcoming ICCR-7 Meeting

Tags: public plans meeting regulation

 

Morning After Pill Access Expanded as Judge Blasts FDA Delay

2013-04-06 05:25:19| Biotech - Topix.net

The "morning after" pill can be made available nationwide to women of all ages and without a prescription, a federal judge ruled, dealing a blow to U.S. restrictions on access to the contraceptive.

Tags: access morning expanded delay

 

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