application
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US FDA clears investigational new drug application, phase 2B trial for Immuron’s NASH/Fatty liver therapeutic
Immuron announced that the United States Food and Drug Administration (US FDA) had cleared an Investigational New Drug (IND) submission to commence a Phase 2b clinical trial of its bovine colostrum-derived therapeutic (IMM-124E) for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Fatty Liver.
application | 06 March 2012
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Ironwood and Forest submit of new drug application for linaclotide
Ironwood Pharmaceuticals Inc and Forest Laboratories Inc announced they have recently submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of…
application | 10 August 2011
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From cancer research to innovative applications: The Dutch revolution
Cancer is expected to strike 26 million people by 2030, adding immense pressure on the global healthcare industry to provide novel and innovative solutions.
application | 01 July 2011
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Novartis application for expanded Menveo indication accepted for FDA review
Novartis announced that the US FDA has accepted for review its supplemental Biologics License Application (sBLA) to expand the Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) indication to include…
application | 16 June 2011
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Affymax, Takeda submit new drug application for anemia treatment
Affymax Inc and Takeda Pharmaceutical Company Limited announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA). This is for the investigational agent peginesatide (formerly known as Hematide) for the treat…
application | 01 June 2011
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Pfizer files new drug applications for crizotinib in the US and Japan
Pfizer Inc announced that its new drug application (NDA) for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor, has been accepted for filing and granted priority review status by the US Food and Drug Administration (FDA) a…
application | 18 May 2011
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FDA accepts new drug application for investigational compound dapagliflozin
Marketing authorisation application for dapagliflozin also validated by European Medicines Agency
application | 09 March 2011
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Biotage launches extraction applications
Biotage launched a series of application notes utilizing the industry-standard RapidTrace SPE Workstation. Applications include extractions from plasma, urine and whole blood, typically assayed in clinical and forensic protocols. Additionally, a…
application | 09 March 2011
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US FDA accepts new drug application for Gadovist 1.0
Bayer announces that the US FDA has accepted for filing a new drug application for gadobutrol injection, a gadolinium-based contrast agent for magnetic resonance imaging (MRI). Gadovist 1.0 (gadobutrol injection) is a macrocyclic, non-ionic gadol…
application | 23 August 2010
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Biotage Releases Catalog for Sample Preparation Products and Applications
Biotage has released its Sample Preparation Catalog. The 176-page catalog includes a range of products including Bioanalytical and Clinical applications. This catalog offers an applications index with links, along with comprehensive information t…
application | 07 May 2010
