Home license application
 

Keywords :   


Tag: license application

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

Tags: review application license accepts

 

Pfizer Announces FDA Acceptance Of And Priority Review Designation For Biologics License Application For Investigational Meningococcal B Vaccine

2014-09-03 12:22:48| drugdiscoveryonline Home Page

Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds

Tags: review application license acceptance

 
 

Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma

2014-05-06 14:40:00| Merck.com - Corporate News

Dateline City: BOSTON Priority Review Designation for MK-3475 BLA for Proposed Indication of Unresectable or Metastatic Melanoma in Patients Who Have Been Previously Treated with Ipilimumab Advancing New Phase 3 Studies with MK-3475 in Adjuvant Melanoma, Previously-Untreated Non-Small Cell Lung Cancer, Advanced Head & Neck and Bladder Cancers Data from Studies in Three Different Cancer Types to be presented at 2014 ASCO Annual Meeting Initiating Phase 1 Study with Investigational Anti-GITR Antibody (MK-4166) BOSTON--(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 MK-3475, Mercks investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. Language: English Contact: MerckMedia:Ian McConnell, 973-901-5722Claire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: advanced review application license

 

FDA Accepts for Review Mercks Biologics License Application for V503, Investigational 9-valent Human Papillomavirus Vaccine

2014-02-20 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, announced today that the Biologics License Application for V503, its investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the U.S. Food and Drug Administration. About Merck Language: English Contact: MerckMedia Contacts:Pamela Eisele, 267-305-3558Imraan Munshi, 215-652-0059orInvestor Contacts:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: review application human license

 

Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma

2014-01-13 14:30:00| Merck.com - Research & Development News

Dateline City: WHITEHOUSE STATION, N.J. Expects to Complete Application in First Half of 2014 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, said today it has started a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for MK-3475, the companys investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab. A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. Language: English Contact: MerckMedia:Ian McConnell, 908-423-3046Claire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-500-1101Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: with advanced application license

 

Sites : [1] [2] [3] [4] [5] [6] [7] next »