submission
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Furiex confirms Takeda's resubmissions of alogliptin NDAs to US FDA
Furiex Pharmaceuticals Inc confirmed that Takeda Pharmaceutical Company Limited has resubmitted two new drug applications (NDAs) for alogliptin to the US Food and Drug Administration (FDA). One application is for marketing approval of alogliptin, and…
submission | 27 July 2011
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J&J to Make 80 Submissions in Next Two Years
Johnson & Johnson Medical Devices & Diagnostics (MD&D) segment has received more than a dozen regulatory approvals so far this year, and it plans to make approximately 80 significant submissions from across its seven franchises between 2010 and 2012…
submission | 14 June 2010
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Astrazeneca Withdraws Regulatory Submissions for Cancer Drug
AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), from the US Food and Drug Administration (FDA) and the Europ…
submission | 12 November 2009
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AstraZeneca announces European Seroquel XR submission for the treatment of GAD
AstraZeneca has its submission of Seroquel XR (quetiapine fumarate extended release tablets) to European regulatory authorities seeking approval for both short-term and maintenance treatment of Generalised Anxiety Disorder (GAD). This is the firs…
submission | 21 October 2008
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ISI, CAC Corp Host Inaugural Submissions-focused Event for Life Science Organizations
Image Solutions Inc (ISI) said it will be hosting its inaugural eSolutions Japan: The Global Submission Environment on May 15, 2007. The provider of software and service solutions to support the drug development lifecycle company has entered the …
submission | 14 May 2007
