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FDA approves orphan drug vandetanib
7 April 2011 | By AstraZeneca
AstraZeneca today announced that the FDA approved the orphan drug vandetanib for the treatment of medullary thyroid cancer...
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FDA Approves YERVOY™ (ipilimumab)
25 March 2011 | By Bristol-Myers Squibb Company
For the Treatment of Patients with Newly Diagnosed or Previously-Treated Unresectable or Metastatic Melanoma, the Deadliest Form of Skin Cancer...
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FDA advisory committee recommends US approval of Novartis once-daily bronchodilator QAB149 for COPD
9 March 2011 | By Novartis
An advisory committee recommended that the FDA approve QAB149 (indacaterol) in the US...
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FDA accepts new drug application for investigational compound Dapagliflozin for the treatment of type 2 diabetes
8 March 2011 | By AstraZeneca
The US FDA has accepted for review a New Drug Application (NDA) for dapagliflozin...
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Onglyza™ US label update provides further evidence regarding use in renally impaired adults with type 2 diabetes
23 February 2011 | By AstraZeneca
The FDA has approved the inclusion of data from two clinical studies...
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US FDA assigns new PDUFA date for BRILINTA (ticagrelor tablets)
4 February 2011 | By AstraZeneca
AstraZeneca announced today that the US FDA has acknowledged receipt of the company’s reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA)...
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FDA approves the Novartis quadrivalent meningococcal conjugate vaccine, Menveo®
31 January 2011 | By Novartis
The FDA approval of Menveo for use in children 2 to 10 years of age is based on Phase III trial data involving 5,297 participants in that age group...
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FDA approves Rituxan/MabThera for first-line maintenance use in follicular lymphoma
31 January 2011 | By Roche
Roche announced that the U.S. FDA approved Rituxan/MabThera as a maintenance treatment for patients with advanced follicular lymphoma...
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AstraZeneca Replies To The US FDA Complete Response Letter For BRILINTA (Ticagrelor Tablets)
21 January 2011 | By AstraZeneca
AstraZeneca announced it has replied to the US FDA Complete Response Letter received for the ticagrelor (BRILINTA) New Drug Application...
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U.S. Food and Drug Administration (FDA) votes to recommend non-approval of liprotamase
12 January 2011 | By Eli Lilly and Company
Eli Lilly announces that the FDA Gastrointestinal Drugs Advisory Committee has recommended that additional studies be conducted...
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PharmaNet Offers Guidance on Regulatory Pathway for Biosimilars Development Following Recent FDA Hearing
20 December 2010 | By The Scott Partnership
PharmaNet, are available to offer guidance on the regulatory pathway for biosimilar development...
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Advisory Committee Briefing Materials For Brilinta (Ticagrelor) NDA Available On US FDA Web Site
26 July 2010 | By AstraZeneca
The FDA posted briefing materials in advance of 28th July 2010 CRDAC to discuss the New Drug Application (NDA) filed by AstraZeneca...
